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

Model Number	48329000
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; when removing the inserter, physician realized there was no resistance in locking mechanism.Upon further inspection on back table, scrub tech noticed the small retaining pin was missing.Missing pin was found.
Additional Manufacturer Narrative
No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.The instrument has been used without an issue more than 100 times over the years.It is likely that the device fractured due to normal wear and tear of instruments.
Event or Problem Description
It was reported that; when removing the inserter, physician realized there was no resistance in locking mechanism.Upon further inspection on back table, scrub tech noticed the small retaining pin was missing.Missing pin was found.

• 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: 6699422
• Report Number: 0009617544-2017-00279
• Device Sequence Number: 11022466
• Product Code: LXH
• UDI-Device Identifier: 07613327267600
• UDI-Public: (01)07613327267600
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2017

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 Model Number: 48329000
• Device Catalogue Number: 48329000
• Device Lot Number: 144203
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2017
• Supplement Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 07/10/2017
• Supplement Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1