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

Catalog Number	48770410
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removing fixation pin from patient, the pin snapped off.
Additional Manufacturer Narrative
Lot# t5x; visual inspection; device history review; complaint history review; risk assessment.No material or manufacturing defects were found.Material analysis confirmed the fixation pin fractured in a mode of torsional ductile overload.The probable root cause is not determined.
Event or Problem Description
It was reported that removing fixation pin from patient, the pin snapped off.

• 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: 6267901
• Report Number: 0009617544-2017-00019
• Device Sequence Number: 731557
• Product Code: LXH
• UDI-Device Identifier: 07613327273038
• UDI-Public: (01)07613327273038
• Combination Product (Y/N): N
• 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): 03/28/2017

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: 48770410
• Device Lot Number: T5X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2017
• Supplement Report FDA Received Date: 03/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1