MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR TEMPORARY FIXATION PIN; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48770410
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/13/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while completing a c6-7 acdf, upon removal of the temporary fixation pin, the pin snapped in half, leaving the distal portion (approx 6-8mm) in-situ on the right side of c6.
Additional Manufacturer Narrative
Method: visual inspection;device history review; complaint history review; risk assessment results: the tip of the fixation pin was confirmed to be fractured away.No other anomalies were identified.Manufacturing history was reviewed and no anomalies were found conclusion: the plausible root cause is hard bone quality of the patient.
Event or Problem Description
It was reported that while completing a c6-7 acdf, upon removal of the temporary fixation pin, the pin snapped in half, leaving the distal portion (approx 6-8mm) in-situ on the right side of c6.

• Brand Name: AVIATOR TEMPORARY FIXATION PIN
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5489942
• Report Number: 0009617544-2016-00110
• Device Sequence Number: 272457
• Product Code: LXH
• UDI-Device Identifier: 07613327273038
• UDI-Public: (01)07613327273038
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2016

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: 48770410
• Device Lot Number: N2B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2016
• Supplement Report FDA Received Date: 05/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1