QUAD CUTTER
Received Jan 31, 2024 · Event occurred Jan 8, 2024
Report 1219602-2024-00188 · MDR key 18614632
Device
Generic name
Stripper, Surgical
Manufacturer
Smith & Nephew, Inc.Catalog number
72205610
Lot number
51072416
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
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). H3, H6: 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 NO 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 AN ACL PROCEDURE, IT WAS NOT POSSIBLE TO GET THE BLADE OUT OF THE QUAD CUTTER, THE CUTTER DETACHED FROM THE SHAFT. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
H10: INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4).