QUAD CUTTER
Received Nov 28, 2023
Report 1219602-2023-02318 · MDR key 18222033
Device
Generic name
Stripper, Surgical
Manufacturer
Smith & Nephew, Inc.Catalog number
72205610
Lot number
51072413
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H10: INTERNAL COMPLAINT REFERENCE: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE CUTTER MECHANISM OF THE QUAD CUTTER BROKE OFF FROM THE SHAFT WHEN THE BLADE WAS BEING REMOVED. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT AND IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY.
Additional Manufacturer Narrative
THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT IT IS NOT IN ITS ORIGINAL PACKAGING. THE OUTER BLADE, PROXIMAL CUTTER IS FRACTURED AWAY FROM THE SHAFT. THE EDGES ARE DEFORMED AND HAVE SLIVERS OF METAL SHORN AWAY. THERE ARE SEVERAL SCUFFS IN THE METAL FROM TOOTHED INSTRUMENTS. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. THE ROOT CAUSE HAS BEEN ASSOCIATED WITH UNINTENDED USE OF THE DEVICE. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE EXCESSIVE FORCE ON THE DEVICE, ATTEMPTED CORRECTION OF A DAMAGED DEVICE, OR AN INADVERTENT IMPACT EVENT INCONSISTENT WITH NORMAL USE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.