NA 328.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982191441), received between Apr 19, 2017 and Jan 15, 2019 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE LOCKING SLEEVE ON THE TISSUE RETRACTOR BROKE WHEN TRYING TO REMOVE A NUT AFTER THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE NUT HAS A MISSING CHIP OUT OF IT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8249412 ↗
• MalfunctionApr 19, 2017Fracture; Component Missing; Detachment of Device or Device Component; Fracture; Component Missing; Detachment of Device or Device Component

  IT WAS INITIALLY REPORTED THAT A SOFT TISSUE RETRACTOR DEVICE WAS FOUND TO BE MISSING A PIECE UPON INSPECTION AFTER STERILE PROCESSING. IT IS UNKNOWN WHEN THE COMPONENT PIECE WAS LOST. THERE WAS NO REPORTED PATIENT OR SURGICAL INVOLVEMENT. THIS EVENT WAS INITIALLY DETERMINED TO BE A NON-REPORTABLE EVENT. UPON RETURN OF THE INSTRUMENT TO THE SYNTHES MANUFACTURER, THE REPAIR TECHNICIAN REPORTED THE BLADE WAS MISSING, AND THE LOCKING NUT WAS CHIPPED AND MISSING A PIECE. THE EVENT WAS REEVALUATED AND DETERMINED TO BE REPORTABLE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6504286 ↗