MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR TEMPORARY FIXATION PIN; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	48770410
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of an aviator temporary fixation pin tip fractured intra-operatively.There were no adverse consequences to the patient and the procedure was completed successfully with a less than 5 minute surgical delay.
Additional Manufacturer Narrative
Visual inspection was performed.The pin fractured at the threads as reported.Material analysis was performed on a similar complaint: "the fixation pin was found to have fractured via torsional ductile overload.The elemental constituents were consistent with what is specified on the print.No material or manufacturing defects were found." device and complaint history was reviewed and no relevant manufacturing issues or similar complaints were identified.The most likely cause of the reported event, based on the material analysis review, is application of torsional ductile overload by the user during pin removal.
Event or Problem Description
It was reported that the tip of an aviator temporary fixation pin tip fractured intra-operatively.There were no adverse consequences to the patient and the procedure was completed successfully with a less than 5 minute surgical delay.

• Brand Name: AVIATOR TEMPORARY FIXATION PIN
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9921143
• Report Number: 0009617544-2020-00054
• Device Sequence Number: 3436223
• Product Code: LXH
• UDI-Device Identifier: 07613327273038
• UDI-Public: 07613327273038
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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: Health Professional
• Device Model Number: 48770410
• Device Catalogue Number: 48770410
• Device Lot Number: 190003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 07/25/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR