NA 309.250Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982185686), received between Sep 17, 2020 and Dec 14, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2021Defective Device; Device-Device Incompatibility; Defective Device; 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 REVISION SURGERY TO REMOVE TCP IMPLANTS. IN THE REVISION SURGERY, THE 2.7MM LOCKING SCREW BROKE DURING REMOVAL. WHEN REMOVING THE BROKEN LOCKING SCREW REMAINING IN THE BONE, THE SURGEON SCRAPED AROUND THE LOCKING SCREW WITH THE 2.7MM HOLLOW REAMER AND USED THE 2.7MM EXTRACTION BOLT, BUT THE BOLT AND THE LOCKING SCREW DID NOT ENGAGE WELL. EVENTUALLY, THE BROKEN LOCKING SCREW WAS REMOVED. THE SURGERY WAS COMPLETED WITHIN 30 MINUTES DELAY. THE PATIENT CONDITION WAS STABLE. ON (B)(6) 2020, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY TREATING DISTAL RADIUS WITH TCP IMPLANTS. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) HOLLOW REAMER-COMPLETE FOR 2.7MM SCREWS. THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13002532 ↗
• MalfunctionAug 19, 2021Break; Break

  IT WAS REPORTED THAT, THE ORDERED REPLACEMENT PART FOR THE BROKEN SCREW SET OF HOLLOW REAMER WAS NOT ABLE TO BE SEPARATED AND THE PARTS SEEM TO BE COLD-WELDED TOGETHER. THIS REPORT IS FOR ONE (1) HOLLOW REAMER-COMPLETE FOR 2.7MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12342696 ↗
• MalfunctionSep 17, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE UPON ROUTINE INSPECTION AT THE DEPUY SYNTHES (B)(6) METRO OFFICE OF THE OFFICE LOANER UNKNOWN SCREW REMOVAL SET, THE HOLLOW REAMER WAS FOUND TO BE DEFECTIVE OR NON-FUNCTIONING. THERE WAS NO PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLLOW REAMER-COMPLETE FOR 2.7MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10551288 ↗