MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVS PL INSERTER 11MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48350952
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/13/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during surgery, a surgeon found the wear of the inserter tip.The surgeon mentioned that the wearing tip is likely to damage the dura mater.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.The device was inspected and slight deformation was found on both tips of the inserter.No relevant issues were identified in the manufacturing records.The possible root cause of the reported event is due to normal wear and tear of instruments.
Event or Problem Description
It was reported that; during surgery, a surgeon found the wear of the inserter tip.The surgeon mentioned that the wearing tip is likely to damage the dura mater.

• Brand Name: AVS PL INSERTER 11MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas NJ 33610 ; FR 33610
• MDR Report Key: 6104652
• Report Number: 0009617544-2016-00452
• Device Sequence Number: 795023
• Product Code: LXH
• UDI-Device Identifier: 07613327267990
• UDI-Public: (01)07613327267990
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48350952
• Device Lot Number: 14E979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2016
• Supplement Report FDA Received Date: 01/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1