NA 03.221.016Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982076762), received between Jul 2, 2019 and Mar 31, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, A CABLE BROKE INSIDE OF THE TENSIONER AND COULD NOT BE REMOVED. PROCEDURE WAS COMPLETED WITH A DELAY OF TEN MINUTES. THIS REPORT IS FOR A Ø1.0MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13967809 ↗
• MalfunctionJun 5, 2020Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, WHEN THE SURGEON WAS TIGHTENING 1.7 MM CABLES, USING THE PISTOL GRIP GUN, THE CABLE LOCK ON THE BACK END OF THE GUN WOULD NOT STAY IN THE LOCKED POSITION. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: CABLE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), CABLE TENSIONER (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 1.0MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10122769 ↗
• MalfunctionJul 2, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING THE TIGHTENING OF A CABLE, THE CABLE LOCK WAS SLIPPING. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: CABLE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A CABLE LOCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8752875 ↗