MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVS AS SPACER INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48329000
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	04/25/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during the surgery, the spacer inserter can't catch the cage.Update (b)(6) 2016: surgery was completed with another competitor's instrument.Surgeon not satisfied with position of the cage.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment; this instrument was manufactured more than 2 years prior to the reported event.Additionally per email correspondence with the sales rep, the instrument is used 2-3 times a week.The instrument ifu states that device life depends on number of uses.It is likely that the cause of the reported event is normal material wear over time.
Event or Problem Description
It was reported that; during the surgery, the spacer inserter can't catch the cage.Update (b)(6) 2016: surgery was completed with another competitor's instrument.Surgeon not satisfied with position of the cage.

• Brand Name: AVS AS SPACER INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5743509
• Report Number: 0009617544-2016-00247
• Device Sequence Number: 13608553
• Product Code: LXH
• UDI-Device Identifier: 07613327267600
• UDI-Public: (01)07613327267600
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2016

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: 48329000
• Device Lot Number: 140618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2016
• Supplement Report FDA Received Date: 10/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1