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

Model Number	48770410
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; doctor doing occipital fusion wanted a temporary fixation pin.He asked to get a set and used the pin to secure plate onto the occiput.Update 5/3/2017: the fixation pin broke.
Additional Manufacturer Narrative
Method: risk assessment.Result: device inspection could not be completed due to no parts or lots provided.Conclusion: the possible root cause of the event is patient hard bone.
Event or Problem Description
It was reported that; doctor doing occipital fusion wanted a temporary fixation pin.He asked to get a set and used the pin to secure plate onto the occiput.Update 5/3/2017: the fixation pin broke.

• 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: 6595239
• Report Number: 0009617544-2017-00225
• Device Sequence Number: 10964688
• Product Code: LXH
• UDI-Device Identifier: 07613327273038
• UDI-Public: (01)07613327273038
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 08/24/2017

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: 48770410
• Device Catalogue Number: 48770410
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: 05/02/2017
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1