QUAD CUTTER
Received Nov 23, 2023
Report 1219602-2023-02280 · MDR key 18198636
Device
Generic name
Stripper, Surgical
Manufacturer
Smith & Nephew, Inc.Catalog number
72205610
Lot number
51072416
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INTERNAL COMPLAINT REFERENCE CASE (B)(4). A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.
Description of Event or Problem
IT WAS REPORTED THAT, AFTER A PROCEDURE, THE TIP OF THE QUAD CUTTER BROKE WHEN THE DISPOSABLE BLADE WAS REMOVED. AS THE EVENT HAPPENED AFTER THE PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
H10: INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4).