NA 03.111.600Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886982072467), received between Apr 2, 2018 and Apr 22, 2026 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 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 24957583 ↗
• MalfunctionNov 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE GUIDE LOCK WOULD NOT ALLOW THE CORTICAL SCREWS TO LOCK.

  Patient problems: Insufficient Information

  MAUDE report 20592314 ↗
• MalfunctionMay 1, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN OSTEOSYNTHESIS FOR THE DISTAL END OF THE RIGHT RADIUS. THE SURGEON PLACED THE GUIDING BLOCK ON A PLATE AND SET THE DRILL SLEEVE. HOWEVER, THE TIP OF THE DRILL SLEEVE COULD ONLY GO ABOUT 2 MM INTO THE SECOND HOLE FROM THE RADIAL SIDE OF THE GUIDING BLOCK. THEREFORE, THE SECOND HOLE FROM THE RADIAL SIDE OF THE PLATE WAS DRILLED WITH THE GUIDING BLOCK REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, WHEN THE GUIDING BLOCK AND DRILL SLEEVE WERE CHECKED, THE HOLE OF THE GUIDING BLOCK WAS OBSERVED TO BE DEFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/RIGHT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19225089 ↗
• MalfunctionAug 31, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AND MONTH IN 2023, THE TRAYS AND INSTRUMENTS WERE BROKEN. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/RIGHT. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662962 ↗
• MalfunctionFeb 10, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF FOR DISTAL RADIUS FRACTURE WITH THE PRODUCTS IN QUESTION. AFTER ABOUT THREE LOCKING SCREWS WAS INSERTED IN THE PLATE DISTAL HOLE, THE SURGEON TRIED TO ATTACH A QUICK DRILL SLEEVE IN QUESTION TO THE SECOND ROW PROXIMAL HOLE ON THE RADIAL SIDE, BUT HE COULD NOT ATTACH. HE TRIED SEVERAL TIMES BUT JUST COULDN'T GET THE QUICK DRILL SLEEVE TO ATTACH. THE GUIDING BLOCK WAS REMOVED AND THE SCREW WAS INSERTED USING A DRILL SLEEVE IN VA FIXATION MODE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE SALE REP INSPECTED THE INSTRUMENTS AND FOUND THAT ONLY THAT HOLE COULD NOT ATTACH THE QUICK DRILL SLEEVE. SINCE OTHER HOLES AND DIFFERENT GUIDING BLOCKS COULD BE ATTACHED WITHOUT ANY PROBLEM, IT IS THOUGHT THAT THE HOLE PROXIMAL TO THE SECOND ROW ON THE RADIAL SIDE OF THE GUIDING BLOCK WAS DEFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/RIGHT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16351306 ↗
• MalfunctionMay 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN JAPAN THAT ON (B)(6) 2022, A PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE PLATE IN QUESTION. ACCORDING TO THE REPORT, THE SURGEON TRIED TO APPLY A TEMPORARY FIXATION WITH A F 1.2 MM K WIRE TO THE DISTAL ULNAR SIDE OF THE PLATE BUT FELT THAT THE K-WIRE INTERFERED WITH THE PLATE. IT WAS REPORTED THAT THE SURGEON CHECKED THE PLATE AND FOUND THAT THERE WAS A SCRATCH ON THE DISTAL SIDE OF THE PLATE. IT WAS REPORTED THAT THE SCRATCH WAS SEEMED TO BE SHAVED BY THE K-WIRE. IT WAS REPORTED THAT THE SURGEON DETACHED A GUIDING BLOCK AND RE-ATTACHED IT, AND THE K WIRE COULD PASS THROUGH THE PLATE, AND HE CONTINUED THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14501488 ↗
• MalfunctionApr 20, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE TWO-COLUMN SMALL PLATE FOR LEFT AND THE GUIDING BLOCK. AFTER THE NURSE ATTACHED THE GUIDING BLOCK TO THE TWO-COLUMN SMALL PLATE WITH HAND, THE SURGEON TRIED TO FIX THE GUIDING BLOCK USING THE SCREWDRIVER. HOWEVER, THE SURGEON COULD NOT TIGHTEN THE ATTACHMENT SCREW, SO THAT WHEN THE SURGEON REMOVED THE GUIDING BLOCK, THE TIP OF THE ATTACHMENT SCREW WAS BROKEN AND REMAINED IN THE PLATE. THE SURGEON REMOVED THE BROKEN FRAGMENT USING PLIERS AND OTHER INSTRUMENTS AND CONFIRMED THAT THERE WERE NO FRAGMENTS IN THE PATIENT¿S BODY. THE SURGEON USED THE DRILL SLEEVE AFTER REMOVING THE BROKEN FRAGMENTS, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PRODUCTS WERE SHIPPED TO THE CONSIGNMENT RETURN SECTION AS THEY WERE CONSIGNMENT PRODUCTS. THIS REPORT IS FOR THE GUIDING BLOCK. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14163417 ↗
• InjuryOct 20, 2021Break; Entrapment of Device; Break; Entrapment of Device

  THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12664335 ↗
• MalfunctionOct 7, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, DURING THE STERILE PROCESS THE REDUCTION FORCEPS POINTS BROAD-RATCHET TIP WAS FOUND BROKEN, T15 CANN STRDRV SCRWDRVR SFT SLF-RETAIN WAS STRIPED, & GUIDE BLOCK FOR 2 COLM PL 6 HOLE HEAD/RT HOLES WERE NOT SMOOTH FOR DROP-IN GUIDE. THE HOLES DO NOT LINE UP WITH THE PLATES ANYMORE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) GUIDE BLOCK FOR 2 COLM PL 6 HOLE HEAD/RT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12594449 ↗
• MalfunctionJul 15, 2021Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE DISTAL RADIUS GUIDE BLOCK WAS NOT THREADING ON THE PLATE AND IT LOOKS LIKE IT WAS BENT AND CROSS THREADED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A DISTAL RADIUS GUIDE BLOCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12172412 ↗
• MalfunctionNov 18, 2020Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT SURGERY FOR A RIGHT DISTAL RADIUS FRACTURE. DURING THE SURGERY, THE SURGEON TRIED TO CONNECT THE GUIDING BLOCK TO THE PLATE, BUT THEY COULDN¿T BE CONNECTED COMPLETELY AND THERE WAS A GAP BETWEEN THE PLATE AND GUIDING BLOCK. THEY WERE DISCONNECTED ONCE AND HE TURNED THE SCREW OF THE GUIDING BLOCK, BUT HAD DIFFICULTY IN TURNING THE SCREW. THE SURGEON TRIED TO CONNECT THEM AGAIN AND WHEN HE USED AN UNKNOWN SCREWDRIVER TO CONNECT THEM, THE SCREW OF THE GUIDING BLOCK WAS BROKEN AND THE FRAGMENT REMAINED IN THE PLATE. THE PLATE COULD NO LONGER BE USED, ANOTHER PLATE WAS USED AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A TWENTY (20) MINUTE DELAY. THERE WAS NO EFFECT TO THE PATIENT. CONCOMITANT DEVICE: UNKNOWN SCREWDRIVER (PART# 03.111.600, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/RIGHT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10862241 ↗
• MalfunctionNov 2, 2020Material Deformation; Material Deformation

  IT WAS REPORTED ON (B)(6) 2020, THAT WHILE RESTOCKING THE TRAY IT WAS NOTICED THE SCREW IN THE PLATE FRILL GUIDE BLOCK WAS BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/ RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10771144 ↗
• MalfunctionAug 24, 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 THE SURGERY FOR DISTAL RADIUS FRACTURES BY USING THE VA-LCP SYSTEM. DURING THE SURGERY, THE SURGEON ATTACHED THE GUIDING BLOCK ONTO THE PLATE AND INSERTED THE HOSPITAL-OWNED K-WIRE THROUGH THE K-WIRE HOLE OF THE GUIDING BLOCK AT DISTAL END. SURGEON FELT SOMETHING UNUSUAL WITH AN INSERTING ANGLE OF THE K-WIRE IN AN IMAGE INTENSIFIER. AS HE TOOK OUT THE PLATE, HE FOUND THAT THE K-WIRE WAS INSERTED OUTSIDE OF THE PLATE BECAUSE THE K-WIRE HOLE OF THE GUIDING BLOCK WAS BIGGER THAN USUAL. BY USING ANOTHER K-WIRE HOLE, HE COMPLETED THE SURGERY SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: GUIDE/COMPRESSION/K-WIRES: TRAUMA (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), VA-LCP DISTAL RADIUS PLATE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT INVOLVES ONE (1) GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/RIGHT. THIS IS REPORT 1 OF 1 (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10443331 ↗
• MalfunctionAug 12, 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 SURGERY FOR DISTAL RADIUS FRACTURES BY USING THE VA-LCP SYSTEM. DURING THE SURGERY, THE SURGEON ATTACHED THE GUIDING BLOCK ONTO THE PLATE AND INSERTED A K-WIRE THROUGH THE K-WIRE HOLE OF THE GUIDING BLOCK AT DISTAL END. THE SURGEON FELT SOMETHING UNUSUAL WITH AN INSERTING ANGLE OF THE K-WIRE IN AN IMAGE INTENSIFIER. AS HE TOOK OUT THE PLATE, HE FOUND THAT THE K-WIRE WAS INSERTED OUTSIDE OF THE PLATE BECAUSE THE K-WIRE HOLE OF THE GUIDING BLOCK WAS BIGGER THAN USUAL. BY USING ANOTHER K-WIRE HOLE, HE COMPLETED THE SURGERY WITH LESS THAN THIRTY (30) MINUTE DELAY. THE SURGEON THOUGHT THAT THE K-WIRE HOLE WAS LIKELY MADE BIGGER WHEN HE INSERTED A K-WIRE, BUT THE K-WIRE WAS NOT STUCK IN THE GUIDING BLOCK, THEREFORE, IT IS UNTHINKABLE THAT THE HOLE WAS MADE BIGGER DURING THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS REPORTED AS STABLE. CONCOMITANT DEVICE REPORTED: GUIDE/COMPRESSION/K-WIRES: TRAUMA (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), VA-LCP DISTAL RADIUS PLATE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10396185 ↗
• InjuryJan 21, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT A SURGERY WITH THE GUIDING BLOCK AND THE SCREW FOR GUIDING BLOCK. WHILE A PLATE WAS SET WITH THE GUIDING BLOCK AND A CORTEX SCREW WAS INSERTED INTO A PROXIMAL HOLE USING THE QUICK DRILL SLEEVE, THE GUIDING BLOCK WAS UNSTABLE. WHEN THE SCREW WAS TURNED IN THE GUIDING BLOCK THE SCREW BROKE AND THE GUIDING BLOCK CAME OFF. THE TIP OF THE SCREW FOR GUIDING BLOCK REMAINED INTO THE PLATE SO A LONGER PLATE WAS USED INSTEAD, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH LESS THAN 30 MINUTES DELAY. THE ADDITIONAL INCISION WASN¿T NEEDED TO USE THE LONGER PLATE. CONCOMITANT DEVICES: UNKNOWN PLATES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), QUICK DRILL SLEEVE 2.4 W/SCAL F/DRILL BI (PART# 03.111.000, LOT# UNKNOWN, QUANTITY# 1), GUIDING BLOCK F/2-COLUMN DIST-RAD-PL2.4 6 (PART# 03.111.600, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN SCREWS: CORTEX (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/RIGHT. . THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9612577 ↗
• MalfunctionOct 28, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SOME OF THE 2.4MM CORTEX SCREWS WERE NOT FITTING THROUGH THE PLATE GUIDES FOR THE TWO COLUMN VARIABLE ANGLE DISTAL RADIUS PLATES. THE SET WAS OPENED AND TESTED THE THREE (3) 2.4MM CORTEX SCREWS 20MM, TWO (2) 2.4MM CORTEX 22MM, AND ONE (1) 2.4MM CORTEX 24MM. THE 2.4MM CORTEX SCREWS WOULD NOT FIT THROUGH THE GUIDE BLOCK FOR TWO-COLUMN PLATE 6 HOLE HEAD, GUIDE BLOCK FOR TWO-COLUMN PLATE 7 HOLE HEAD, NOR THE GUIDE BLOCK FOR TWO-COLUMN PLATE NARROW 6 HOLE. THE REST OF THE 2.4MM CORTEX SCREWS DID. THE ISSUE WAS FOUND IN STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICES REPORTED: UNKNOWN CORTEX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS IS 1 OF 9 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9244328 ↗
• MalfunctionAug 28, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR DISTAL RADIUS FRACTURE WITH THE GUIDING BLOCK. AFTER A NURSE ATTACHED THE GUIDING BLOCK TO A PLATE WITHOUT A DRIVER, THE SURGEON LOCATED THE DEVICES IN THE INCISION AND FIXED THEM TEMPORARILY WITH 2 K-WIRES. WHEN THE SURGEON USED A REDUCTION FORCEPS THROUGH THE GUIDING BLOCK, THE GUIDING BLOCK WAS UNSTABLE. AFTER THAT, THE GUIDING BLOCK ATTACHMENT SCREW BROKE, AND THE GUIDING BLOCK CAME OFF. THE FRAGMENT OF THE GUIDING BLOCK ATTACHMENT SCREW REMAINED ON THE PLATE, AND THE SURGEON COULD REMOVE IT. THERE WERE NO PIECES LEFT IN THE PATIENT. THE DOCTOR CONFIRMED IT BY X-RAY. THE SURGERY WAS DELAYED BY LESS THAN THIRTY (30) MINUTES. PATIENT OUTCOME REPORTED AS STABLE. CONCOMITANT DEVICE REPORTED: UNK PLATES: TRAUMA (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY 1), UNK GUIDE/COMPRESSION/K WIRES: TRAUMA (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY 1), UNK FORCEPS: TRAUMA (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/RIGHT. THIS IS REPORT 1 OF 2 FOR C

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8940444 ↗
• MalfunctionMay 21, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, SIX (6) GUIDING BLOCKS FOR A VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) TWO COLUMN DISTAL RADIUS PLATE DID NOT FIT CORRECTLY ON TWO (2) PLATES. A SCREW TO FIX THE GUIDING BLOCKS ON THE PLATE WAS TOO LONG RESULTING IN THE PLATE NOT BEING PLACED PROPERLY ON THE BONE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A PLATE WITH NO GUIDING BLOCK. THERE WAS NO PATIENT HARM OR INTERVENTION REQUIRED THIS REPORT IS FOR A VA-LCP PLATE. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8628995 ↗
• MalfunctionApr 2, 2018Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED, THAT ON (B)(6) 2018, THE FOLLOWING DEVICE WAS USED IN THE OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR DISTAL RADIUS FRACTURE (RIGHT). GUIDING BLOCK F/2-COLUMN DIST-RAD-PL2.4 6. DURING THE SURGERY, THE GUIDING BLOCK ATTACHMENT SCREW BROKE AT THE TIME OF FIXATION TO THE SMALL PLATE. HOWEVER, FIXATION TO THE EXTRA-SMALL PLATE WAS SUCCESSFUL. THE SURGERY WAS COMPLETED WITH A LESS-THAN-30-MINUTE DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7391000 ↗