SMARTSTITCH PERFECTPASSER OM-8176EARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817470005837), received between Dec 12, 2018 and Dec 12, 2018 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K123268); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2018Break

  IT WAS REPORTED THAT, DURING A LEFT SHOULDER CUFF REPAIR SURGERY, IT WAS USED: (A) 1 ANCHOR X OM-6500 SPEEDSCREW LOT 2001966, WITH (B) 1 X OM-8176EA SUTURE MAGNUM WIRE LOT 2008074; DESPITE A GOOD USE OF THE ANCHOR ON THE TENSION OF THE SUTURES, THE SUTURES BROKE WITHOUT LOGICAL EXPLANATION. THE PROCEDURE WAS FINISHED IN MINI-OPEN MODALITY AND USING A COMPETITOR DEVICE. THERE IS NOT REFERENCE TO WHETHER THERE WAS A DELAY IN THE SURGERY OR NOT. NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8156353 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123268. One submission often covers many models, so check the product and lot details in each record.

• Z-3000-2020 · Feb 21, 2019 · Terminated
  Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971