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

Catalog Number	48350952
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the inner shaft of the inserter have been bent when implanting interbody.The bent portion is the threaded, distal tip.
Additional Manufacturer Narrative
Risk assessment.The device was not returned and no lot# was provided.It is likely that the instruments deformed due to normal wear and tear of instruments.
Event or Problem Description
It was reported that; the inner shaft of the inserter have been bent when implanting interbody.The bent portion is the threaded, distal tip.

• Brand Name: AVS PL INSERTER 11MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6517275
• Report Number: 0009617544-2017-00160
• Device Sequence Number: 16146443
• Product Code: LXH
• UDI-Device Identifier: 07613327267990
• UDI-Public: (01)07613327267990
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2017

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: 11111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2017
• Supplement Report FDA Received Date: 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1