NA 03.111.501Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10886982072436), received between Nov 2, 2018 and Apr 22, 2026 — classified as 4 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Break

  DROP IN GUIDE HAS BROKEN AND IS UNUSABLE. GUIDE BLOCKS HAVE ALSO BROKEN WHERE THREADS ARE FOR THE SCREW. ISSUE OCCURRED DURING CONTINUED USE INTRAOPERATIVELY OVER TIME; WAS NOTICED POST-OP DURING REASSEMBLY. DEVICES HAVE BEEN DISCARDED. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957584 ↗
• MalfunctionJan 6, 2026Break; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ORIF FOR DISTAL RADIUS FRACTURE WITH THE GUIDING BLOCK. DURING THE SURGERY, WHEN A STANDARD-SIZED PLATE WAS SELECTED AND THE SURGEON TRIED TO SET UP THE GUIDING BLOCK FOR INSTALLATION, THE SCREW AT THE CONNECTION BROKE, MAKING IT IMPOSSIBLE TO CONNECT. THE SURGEON WAS FORCED TO REMOVE THE CONNECTING SCREW FROM THE OTHER SIZE GUIDING BLOCK AND CONNECT IT TO THE STANDARD GUIDING BLOCK, WHICH ALLOWED THE OPERATION TO PROCEED WITHOUT INTERRUPTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973088 ↗
• MalfunctionJul 28, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2023, THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION SURGERY WITH THE GUIDING BLOCK. THE NURSE ATTEMPTED TO ATTACH THE GUIDING BLOCK TO THE TCP EXTRA SMALL 3-HOLE PLATE, BUT THE SCREW FOR THE GUIDING BLOCK STRUCK AND COULD NOT BE ATTACHED. THE SURGEON WAS UNABLE TO REATTACH IT. EVEN AFTER SLOWLY TURNING THE SCREW FOR THE GUIDING BLOCK WITH A SCREWDRIVER, IT WAS CLEARLY WOBBLING AND COULD NOT BE SECURED. THE IMPLANT WAS THEN FIXED, AND THE SURGERY WAS COMPLETED. AFTER THE SURGERY, IT WAS NOTED THAT THE SCREW FOR THE GUIDING BLOCK IN QUESTION HAD BEEN COMPLETELY SHAVED OFF, SUCH THAT ABOUT ONLY TWO THREADS WERE LEFT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT INVOLVES ONE GUIDE BLOCK FOR TWO-COLUMN PLATE/NARROW 6H HD/LT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413246 ↗
• MalfunctionApr 7, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE SURGERY WITH VA-TCP. IN THE SURGERY, THE SCREW PART OF THE GUIDING BLOCK IN QUESTION BROKE AND REMAINED ON THE PLATE IN QUESTION. THE PLATE WAS NO LONGER AVAILABLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NEW PLATE AND GUIDING BLOCK. THERE WAS NO SURGICAL DELAY. THE PATIENT IS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) GUIDINGBLOCK F/2-COLUMN DIST-RAD-PL2.4 N. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704065 ↗
• MalfunctionDec 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. DURING THE SURGERY, WHEN THE GUIDING BLOCK IN QUESTION WAS ATTACHED TO A PLATE, THE GUIDING BLOCK WAS UNSTABLE. THE SURGEON REATTACHED THE GUIDING BLOCK TO THE PLATE, BUT THE GUIDING BLOCK DID NOT STABILIZE AND REMAINED UNSTABLE. THE GUIDING BLOCK IN QUESTION WAS COMPARED TO OTHER SIZES OF GUIDING BLOCKS, BUT IT SEEMED NOTHING ABNORMAL. IN THE SURGERY, THE PLATE WAS INSERTED WITHOUT USING ANY GUIDING BLOCKS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THE PATIENT OUTCOME WAS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) GUIDE BLOCK FOR TWO-COLUMN PLATE/NARROW 6H HD/LT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13114346 ↗
• MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6), 2021, PATIENT UNDERWENT A PROCEDURE FOR DISTAL RADIUS. THE 2.4MM CORTEX SCREWS IN THE VA DISTAL RADIUS SET DON¿T FIT THROUGH THE DISTAL DRILL GUIDES AND THE SCREW INSTEAD LOCKS THE GUIDE DOWN TO THE BONE. WHILE EXAMINING THE SCREW HEAD IT¿S VISIBLE TO SEE A SLIGHT DIFFERENCE BETWEEN ONES THAT FIT AND THE ONES THAT DON¿T. THE SURGEON TRIED TO USE DISTAL DRILL GUIDE BLOCKS AND THE SCREW WOULDN¿T FIT THROUGH BLOCK WHICH LOCKS THE PLATE TO THE RADIUS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY AND NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT MEDICAL PRODUCTS: UNK - PLATES: VA-LCP DISTAL RADIUS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) GUIDE BLOCK FOR TWO-COLUMN PLATE/NARROW 6H HD/LT. THIS IS REPORT 2 OF 20 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12555038 ↗
• InjurySep 20, 2021Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF DISTAL RADIUS PLATE AND GUIDE BOCK DUE TO MALFUNCTIONED. THE DISTAL RADIUS PLATE AND GUIDE BOCK WERE REMOVED AND WAS REPLACED. THE PRIMARY IMPLANTATION WAS ON (B)(6) 2021. THE DISTAL RADIUS PLATE AND GUIDE BLOCK WERE REMOVED WITH DEFECTS/MALFUNCTION AND WERE REPLACED. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) GUIDE BLOCK FOR TWO-COLUMN PLATE/NARROW 6H HD/LT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12495739 ↗
• InjuryAug 17, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REVISION OF ORIF DISTAL RADIUS. IT WAS NOTED THAT UPON FOLLOW UP THE PATIENT HARDWARE APPEARED TO HAVE LOOSENED PER THE SURGEON AND SUBSEQUENT LOSS OF REDUCTION. INITIALLY, PATIENT HAD A ORIF DISTAL RADIUS ON (B)(6) 2021. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) GUIDE BLOCK TWO-COLM PL/NARROW 6H HD/LT. THIS REPORT IS 3 OF 3 FOR(B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12331101 ↗
• MalfunctionMar 31, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE GUIDE BLOCK WOULD NOT THREAD INTO THE UNKNOWN PLATE. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) GUIDE BLOCK TWO-COLM PL/NARROW 6H HD/LT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11599678 ↗
• MalfunctionAug 28, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT THE OSTEOSYNTHESIS SURGERY FOR A DISTAL RADIUS FRACTURE. DURING THE SURGERY, WHILE A NURSE WAS TRYING TO ATTACH THE GUIDING BLOCK TO THE PLATE, THE SCREW PART OF THE GUIDING BLOCK BROKE. THIS BREAKAGE HAPPENED WHEN THE NURSE ATTACHED THE GUIDING BLOCK TO THE PLATE BY HAND AND FURTHERMORE TIGHTENED THE SCREW PART BY USING THE DRIVER. THE SCREW PART KEPT ROTATING IDLY AND FINALLY BROKE. THE SURGEON USED VA-LCP DRILL SLEEVE 2.4 (03.110.000) TO FIX THE DISTAL LOCKING AND COMPLETED THE SURGERY WITH A LESS-THAN-30-MINUTE DELAY. CONCOMITANT DEVICES REPORTED: VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA (PART# 04.111.541S, LOT# 36P5654, QUANTITY# 1); HANDLE W/QUICK-COUPLER L110 (PART# 311.430, LOT# UNKNOWN, QUANTITY# 1); SCRDRIVER SHAFT T8 SELF-HOLD (PART# 314.467, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) GUIDE BLOCK FOR TWO-COLUMN PLATE/NARROW 6H HD/LT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10466387 ↗
• MalfunctionApr 6, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR DISTAL RADIUS FRACTURE WITH THE GUIDING BLOCK IN QUESTION. DURING THE SURGERY, THE SURGEON TRIED TO PASS K-WIRES THROUGH 2 DISTAL HOLES OF A PLATE THROUGH THE GUIDING BLOCK, BUT HE COULDN'T BECAUSE THE K-WIRES INTERFERED WITH THE PLATE. THE SURGEON REMOVED THEM FROM THE PATIENT, AND CHECKED THEM, BUT THE K-WIRES WOULD NOT PASS THROUGH 2 DISTAL HOLES OF THE PLATE. THE K-WIRES COULD PASS THROUGH THE GUIDING BLOCKS HOLE. THE SURGEON PASSED THE K-WIRES THROUGH THE HOLES WITHOUT THE USE OF THE GUIDING BLOCK, AND THE SURGERY WAS CONTINUED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A THIRTY (30) MINUTE DELAY. THE PATIENT STATUS AFTER THE PROCEDURE WAS STABLE. CONCOMITANT DEVICES REPORTED: PLATES: TRAUMA (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), GUIDE/COMPRESSION/K-WIRES TRAUMA (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT INVOLVES ONE (1) GUIDE BLOCK FOR TWO-COLUMN PLATE/NARROW 6H HD/LT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9929286 ↗
• MalfunctionJan 31, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ROUTINE INCOMING INSPECTION, THE GUIDING BLOCK FOR TWO-COLUMN DISTAL RADIUS PLATE WAS BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9655883 ↗
• InjuryOct 25, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING ON A DISTAL RADIUS SURGERY, THE SURGEON ATTEMPTED TO INSERT A ONE (1) CORTEX SCREW SELF-TAPPING WITH STARDRIVE RECESS THROUGH A ONE (1) GUIDE BLOCK FOR TWO-COLUMN PLATE ON, A ONE (1) VARIABLE ANGLE (VA) NARROW TWO-COLUMN VOLAR DISTAL RADIUS PLATE. THE CORTEX SCREW WOULD NOT FIT THROUGH THE GUIDE BLOCK AND PROCEEDED TO TEST OUT TWO (2) ADDITIONAL CORTEX SCREW ON THE BACK TABLE THROUGH A SEPARATE GUIDE BLOCK AND WAS UNSUCCESSFUL, A VA LOCKING SCREW WAS USED INSTEAD. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: VARIABLE ANGLE (VA) NARROW TWO-COLUMN VOLAR DISTAL RADIUS PLATE (PART #: 02.111.531, LOT #: UNKNOWN, QUANTITY #: 1). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9240788 ↗
• InjuryOct 25, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING ON A DISTAL RADIUS SURGERY, THE SURGEON ATTEMPTED TO INSERT A ONE (1) CORTEX SCREW SELF-TAPPING WITH STARDRIVE RECESS THROUGH A , ONE (1) GUIDE BLOCK FOR TWO-COLUMN PLATE ON, A ONE (1) VARIABLE ANGLE (VA) NARROW TWO-COLUMN VOLAR DISTAL RADIUS PLATE. THE CORTEX SCREW WOULD NOT FIT THROUGH THE GUIDE BLOCK AND PROCEEDED TO TEST OUT TWO (2) ADDITIONAL CORTEX SCREW ON THE BACK TABLE THROUGH A SEPARATE GUIDE BLOCK AND WAS UNSUCCESSFUL, A VA LOCKING SCREW WAS USED INSTEAD. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: VARIABLE ANGLE (VA) NARROW TWO-COLUMN VOLAR DISTAL RADIUS PLATE (PART #: 02.111.531 LOT #: UNKNOWN, QUANTITY #: 1). THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9240753 ↗
• MalfunctionMay 3, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SCRUB TRIED ON THE BACK TABLE AND ONE (1) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 18MM BECAME INCARCERATED IN THE GUIDE BLOCK. ADDITIONALLY, THREE(3) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 12MM, THREE(3) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, THREE(3) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 18MM, ONE (1) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 22MM, TWO (2) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS  24MM, ONE (1) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 28MM WOULD NOT FIT THROUGH THE GUIDE BLOCK. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES SIXTEEN (16) DEVICES. THIS COMPLAINT INVOLVES 16 DEVICES DUE TO THE SYSTEM LIMITATION, THESE INCIDENTS WILL BE CAPTURED UNDER THIS (B)(4) FOR (10 DEVICES) AND LINKED (B)(4) FOR (6 DEVICES). THIS REPORT IF FOR SIX (6) DEVICES. THIS REPORT IS 1 OF 6 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8580076 ↗
• MalfunctionMay 3, 2019Fitting Problem; Device-Device Incompatibility; Device Difficult to Maintain; Fitting Problem; Device-Device Incompatibility; Device Difficult to Maintain

  IT WAS REPORTED THAT ON (B)(6) 2019, A 3 HOLE SHAFT VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS TWO COLUMN 6HH NARROW WAS USED. THE SURGEON ATTEMPTED TO INSERT ONE (1) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 18MM THROUGH THE 6 HOLE GUIDING BLOCK. THE SCREW WOULD NOT FIT THROUGH THE GUIDE. OTHER SCREWS WERE TRIED. TWO (2) ADDITIONAL CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 18MM WOULD NOT FIT THROUGH THE GUIDE AND FINALLY ONE DID. THERE WAS A 5 MINUTES SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS NOT AFFECTED. CONCOMITANT DEVICE REPORTED: 3 HOLE SHAFT VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) (PART #UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IF FOR ONE (1) GUIDE BLOCK FOR TWO-COLUMN PLATE/NARROW 6H HD/LT. THIS REPORT IS 3 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8580065 ↗
• MalfunctionMar 1, 2019Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, AN OPEN REDUCTION INTERNAL FIXATION (ORIF) FOR THE DISTAL RADIUS FRACTURE WAS PERFORMED USING A VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) TWO- COLUMN VOLAR DISTAL RADIUS PLATE. DURING THE SURGERY, THE SURGEON HAD DIFFICULTY ATTACHING THE GUIDING BLOCK INTO THE PLATE. WHEN THE SURGEON TRIED TO DETACH THE GUIDING BLOCK TO REATTACH, THE SCREW OF THE GUIDING BLOCK WAS BROKEN DUE TO A STRONG FORCE BY THE SURGEON UPON TURNING THE GUIDING BLOCK SCREW. THUS, ANOTHER UNKNOWN PLATE WITH FOUR (4) HOLES WAS USED BECAUSE THE SURGEON COULD NOT REMOVE THE FRAGMENT OF THE BROKEN SCREW FROM THE PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT USING THE GUIDING BLOCK. THE SURGERY WAS DELAYED BY LESS THAN THIRTY (30) MINUTES. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE REPORTED: VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) (PART 04.111.531S, LOT 1L78902, QUANTITY 1). THIS REPORT IS FOR ONE (1) GUIDE BLOCK FOR TWO-COLUMN PLATE/NARROW 6H HD/LT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8382027 ↗
• MalfunctionNov 2, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR A DISTAL RADIUS FRACTURE. DURING THE SURGERY, THE SURGEON TRIED TO INSERT A KIRSCHNER WIRE INTO THE DISTAL AREA OF A VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) TWO-COLUMN VOLAR DISTAL PLATE USING A GUIDING BLOCK. HOWEVER, THE WIRE INTERFERED WITH THE PLATE AND COULD NOT BE INSERTED. AFTER THE SURGERY, IT WAS CONFIRMED THAT THE K-WIRE COULD PASS THROUGH THE PLATE DIRECTLY. BUT WHEN THEY TRIED TO USE THE K-WIRE ON THE GUIDING BLOCK DIRECTLY, SOMETIMES THE K-WIRE WOULD NOT PASS THROUGH. ALSO, WHEN USED IN COMBINATION WITH THE TIGHTLY CONNECTED GUIDING BLOCK AND PLATE, THE K-WIRE COULD NOT PASS THROUGH THEM TOO. THE SURGERY WAS COMPLETED SUCCESSFULLY ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS FINISHED. THE SURGERY WAS DELAYED BY LESS THAN THIRTY (30) MINUTES. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR ONE (1) GUIDE BLOCK. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8034438 ↗