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

Model Number	48770410
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of an aviator temporary fixation pin fractured intra-operatively, during insertion at c6.The fractured component was left in the vertebral body.The procedure was completed successfully without surgical delay.No adverse consequences nor medical intervention were reported.
Event or Problem Description
It was reported that the tip of an aviator temporary fixation pin fractured intra-operatively, during insertion at c6.The fractured component was left in the vertebral body.The procedure was completed successfully without surgical delay.No adverse consequences nor medical intervention were reported.
Additional Manufacturer Narrative
The event was confirmed based on visual inspection of the returned device.The aviator temporary fixation pins are made of titanium alloy (ti-6al-4v) implantable-grade material.The elemental constitution was as specified on the drawing.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per the aviator surgical technique guide: excessive pivoting or angulation on the temporary fixation pin inserter should be avoided, as it can cause fracturing of the temporary fixation pins.Temporary fixation pins are recommended for single-use only.It is unknown if a surgeon used complex maneuvers or excessive force during the procedure.The patient's bone quality is unknown.It is also unknown how many times this device has been used/ how long the sales rep had this device for.A material analysis was performed for a previous similar event and found that the fixation pin fractured in a mode of torsional ductile overload.The most likely cause of the reported event based on the material analysis report for previous similar incidents is application of torsional ductile overload to the device.

• Brand Name: AVIATOR TEMPORARY FIXATION PIN
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12450162
• Report Number: 0009617544-2021-00148
• Device Sequence Number: 11646845
• Product Code: LXH
• UDI-Device Identifier: 07613327273038
• UDI-Public: 07613327273038
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

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: 210044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown