QUAD CUTTER
Received Nov 28, 2023 · Event occurred Nov 4, 2023
Report 1219602-2023-02316 · MDR key 18221611
Device
Generic name
Stripper, Surgical
Manufacturer
Smith & Nephew, Inc.Catalog number
72205610
Lot number
51072416
Product problems
- Break
- Material Deformation
- Break
- Material Deformation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AFTER A PROCEDURE, AN ATTEMPT WAS MADE TO REMOVE THE QUAD CUTTER DISPOSABLE BLADE, BUT THE DEVICE BROKE AT THE END. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
H10: INTERNAL COMPLAINT REFERENCE: (B)(4).
Additional Manufacturer Narrative
INTERNAL COMPLAINT REFERENCE (B)(4). H10 H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT IT IS NOT IN ITS ORIGINAL PACKAGING. THE QUAD CUTTER WAS RETURNED WITH THE DISTAL END FRACTURED AWAY FROM THE SHAFT. THE OUTER BLADE HOLDER IS COMPLETELY REMOVED FROM THE SHAFT AND THE DISPOSABLE BLADE IS STUCK IN PLACE. BOTH ARE SCRATCHED AND THE METAL OF BOTH PIECES IS DEFORMED. 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.