NA 398.41.96Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982201393), received between Mar 2, 2017 and Aug 6, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, THE REDUCTION FORCEPS WITH SERRATED JAW-RATCHET WAS BROKEN. IT WAS FURTHER REPORTED THAT THE REDUCTION FORCEPS WITH POINTS BROAD-RATCHET WAS DISCOVERED BROKEN AS WELL STRIPPED AND IT ALSO CAME OUT OF THE SET. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS BROAD-RATCHET 144 MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8865181 ↗
• MalfunctionMar 27, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING FIELD INVENTORY, THE STARDRIVE SCREWDRIVER SHAFT AND TWO (2) REDUCTION FORCEPS WERE FOUND TO HAVE A MALFUNCTION. THE STARDRIVE SCREWDRIVER SHAFT HAS WARPED WEDGES ON THE SIDE. WHILE ONE OF THE REDUCTION FORCEPS WILL NOT HOLD DURING LATCHING/RATCHETING. THE OTHER REDUCTION FORCEPS HAS A BROKEN POINT. IT WAS DISCOVERED WHILE TRYING TO PIECE TOGETHER A SET TO BE USED IN THE ACCOUNT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8457327 ↗
• MalfunctionMar 27, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING FIELD INVENTORY, THE STARDRIVE SCREWDRIVER SHAFT AND TWO (2) REDUCTION FORCEPS WERE FOUND TO HAVE A MALFUNCTION. THE STARDRIVE SCREWDRIVER SHAFT HAS WARPED WEDGES ON THE SIDE. WHILE ONE OF THE REDUCTION FORCEPS WILL NOT HOLD DURING LATCHING/RATCHETING. THE OTHER REDUCTION FORCEPS HAS A BROKEN POINT. IT WAS DISCOVERED WHILE TRYING TO PIECE TOGETHER A SET TO BE USED IN THE ACCOUNT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8457325 ↗
• MalfunctionJan 24, 2018Break; Break

  IT WAS REPORTED THAT DURING INSPECTION OF THE DEVICES IN STERILE PROCESSING DEPARTMENT, IT WAS NOTED THAT THE POINTED CLAMP (ONE OF THE POINTS OF A REDUCTION FORCEPS) WAS BROKEN OFF. THIS ISSUE WAS NOTICED WHILE PUTTING A SET BACK TOGETHER IN STERILE PROCESSING. THERE IS NO REPORTED PATIENT INVOLVEMENT OR HARM. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS BROAD-RATCHET. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7216797 ↗
• MalfunctionMar 2, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT WHILE PERFORMING A SUPRAPATELLAR TIBIAL NAILING PROCEDURE THE SURGEON HAD INSERTED THE TIBIAL NAIL AND WHILE ATTEMPTING TO DRILL FOR THE PROXIMAL INTERLOCKING SCREWS, THE DRILL BIT HIT THE NAIL. THE SURGEON WAS CONCERNED THERE WAS AN ALIGNMENT ISSUE WITH THE SYNTHES AIMING DEVICES. THE SURGEON THEN ATTEMPTED TO DRILL FOR ANOTHER INTERLOCKING SCREW AND WAS SUCCESSFUL. UPON ADDRESSING THE PREVIOUS SCREW, SHE ATTEMPTED TO DRILL AGAIN AND WAS SUCCESSFUL IN DRILLING AND PLACING THE SCREW. THE PATIENT ALSO HAD A DISTAL FIBULA FRACTURE. WHILE TRYING TO PLACE A BONE CLAMP AROUND THE FRACTURE, ONE TIP OF THE REDUCTION FORCEPS BROKE OFF. THE FRAGMENT WAS RETRIEVED AND DISCARDED. THERE WAS A TWO (2) MINUTE DELAY DUE TO THE REPORTED EVENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER CLAMP. THE PATIENT POSTSURGICAL OUTCOME WAS REPORTEDLY FINE. CONCOMITANT DEVICES REPORTED: TIBIAL NAIL (PART #UNKNOWN, LOT # UNKNOWN, QUANTITY 1), DRILL BIT (PART #UNKNOWN LOT #UNKNOWN, QUANTITY 1). THIS REPORT IS 4 OF 4 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6372228 ↗