NA 03.111.700Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982072528), received between Apr 18, 2017 and Apr 22, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 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 24957588 ↗
• MalfunctionNov 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON 10/23/2024, THE GUIDE LOCK WOULD NOT ALLOW THE CORTICAL SCREWS TO LOCK.

  Patient problems: Insufficient Information

  MAUDE report 20592627 ↗
• MalfunctionMay 2, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT OSTEOSYNTHESIS SURGERY FOR LEFT DISTAL RADIUS FRACTURE. IN THE SURGERY, THE GUIDING BLOCK WAS DIFFICULT TO ATTACH TO THE PLATE. AFTER SEVERAL TRIES, THE SURGEON ATTACHED THE GUIDING BLOCK AND MANUALLY TIGHTENED THE CONNECTING SCREW. WHEN THE BACK OF THE PLATE WAS OBSERVED, THE TIP OF THE CONNECTING SCREW PROTRUDED FROM THE BACK OF THE PLATE BY ABOUT 3 MM. THE SURGEON DECIDED THAT THE PROTRUSION WAS NOT WITHIN THE ALLOWABLE RANGE AND REPLACED IT WITH THE SAME PART NUMBER GUIDING BLOCK. THE ISSUE DID NOT REPEAT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR A GUIDE BLOCK FOR 2 COLUMN PLATE 7 HOLE HEAD/RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16852229 ↗
• MalfunctionFeb 23, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A PROCEDURE FOR FRACTURE OF DISTAL RADIUS. DURING THE SURGERY, THE SLEEVE DID NOT FIT INTO THE HOLE LOCATED AT THE DISTAL CENTER OF THE GUIDING BLOCKS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A THIRTY (30) MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) GUIDE BLOCK FOR 2 COLUMN PLATE 7 HOLE HEAD/RIGHT. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13584671 ↗
• MalfunctionFeb 23, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A PROCEDURE FOR FRACTURE OF DISTAL RADIUS. DURING THE SURGERY, THE SLEEVE DID NOT FIT INTO THE HOLE LOCATED AT THE DISTAL CENTER OF THE GUIDING BLOCKS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A THIRTY (30) MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) GUIDE BLOCK FOR 2 COLUMN PLATE 7 HOLE HEAD/RIGHT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13584647 ↗
• MalfunctionDec 23, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, BEFORE THE CASE BEGAN, THE SCRUB TECH WAS CHECKING SCREW FITMENT OF 2.4 CORTEX SCREWS THROUGH THE GUIDE BLOCK OF 2.4 VA-LCP DISTAL RADIUS PLATE AND NOTICED THAT SCREW HEADS WERE NOT FITTING THROUGH GUIDE BLOCK 2.4 SCREW HOLES DISTALLY. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) GUIDE BLOCK FOR 2 COLUMN PLATE 7 HOLE HEAD/RIGHT. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13080197 ↗
• MalfunctionNov 12, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION FOR DISTAL RADIUS FRACTURES. AFTER DRILLING, THE SURGEON TRIED TO INSERT A BUTT-LESS PIN INTO THE DISTAL HOLE BY USING THE DRILL SLEEVE, BUT THE INSERT DIRECTION GOT TO BE A PROXIMAL DOWNWARD. THE SURGEON TRIED TO INSERT A BUTT-LESS PIN AGAIN, BUT THE RESULT WAS THE SAME. FINALLY, THE SURGEON REMOVED THE GUIDING BLOCK AND INSERTED A BUTT-LESS PIN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 10 MINUTES DELAY. THE DRILL SLEEVE WAS QUITE WOBBLED, SO THE INSERTING DIRECTION GOT TO BE IMPROPER DIRECTION. THIS REPORT IS FOR ONE (1) GUIDE BLOCK FOR 2 COLUMN PLATE 7 HOLE HEAD/RIGHT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12805104 ↗
• 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 2 OF 9 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9244323 ↗
• 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 6 OF 8 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8629106 ↗
• MalfunctionJul 12, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A GUIDE BLOCK FOR TWO-COLUMN PLATE BROKE OUTSIDE OF SURGERY. THE SET SCREW THAT ISSUED TO ATTACH THE GUIDE BLOCK TO A DISTAL RADIUS PLATE BROKE. THERE WAS NO PROCEDURE DONE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) GUIDE BLOCK FOR 2 COLUMN PLATE 7 HOLE HEAD/RIGHT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7682245 ↗
• MalfunctionDec 14, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2017, A SET SCREW STRIPPED AND BROKE WHEN THE SURGEON WAS REMOVING THE GUIDE BLOCK JUST BEFORE FINISHING THE SURGERY. NO FRAGMENTS WERE GENERATED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY AND THE PATIENT WAS STABLE AFTER THE SURGERY. THERE IS NO ADDITIONAL INFORMATION. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7117874 ↗
• InjuryApr 18, 2017Break; Material Fragmentation; Break; Material Fragmentation

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED DURING A PROCEDURE TO REPAIR A DISTAL RADIUS FRACTURE ON (B)(6) 2017, SURGEON INSERTED A SCREW INTO A PLATE USING A GUIDE BLOCK. DURING FINAL CHECK PRIOR TO CLOSING, SURGEON NOTED ONE OF THE SCREWS APPEARED TO BE INSERTED IN THE WRONG DIRECTION. TO REINSERT THE SCREW, SURGEON ATTEMPTED TO EQUIP THE PLATE WITH THE GUIDE BLOCK. ALTHOUGH IT APPEARED THAT THE SCREW WAS TIGHTENED, THE GUIDE BLOCK WOULD NOT LOCK. IT WAS THEN NOTICED THAT THE SCREW TIP OF THE GUIDE BLOCK WAS BROKEN AND STUCK TO THE PLATE. SURGEON WAS NOT ABLE TO REMOVE THE BROKEN FRAGMENT FROM THE PLATE. THE PLATE WITH THE FRAGMENT REMAINS IMPLANTED BECAUSE THE BROKEN SCREW TIP DID NOT PROTRUDE ENOUGH TO AFFECT SOFT TISSUE. PROCEDURE WAS DELAYED APPROXIMATELY 5 MINUTES. REVISION SURGERY WILL BE PLANNED WITHIN ONE YEAR AS SURGEON IS CONCERNED ABOUT CORROSION DUE TO THE DIFFERENT TYPE OF METAL ON THE PLATE AND THE BROKEN SCREW TIP. CONCOMITANT MEDICAL PRODUCTS: PLATE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1), SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) GUIDE BLOCK. THIS IS REPORT 1

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6501482 ↗