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	01/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during insertion, the tip of an aviator temporary fixation pin broke off into the vertebral body intra-operatively.The tip could not be retrieved because it broke off beneath the surface of the vertebral body.The procedure was completed successfully without surgical delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual, dimensional, and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Per the surgical technique: 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.The most likely cause of the reported event based on the material analysis report from previous similar incidents is application of torsional ductile overload to the device.Device not returned to stryker.
Event or Problem Description
It was reported that during insertion, the tip of an aviator temporary fixation pin broke off into the vertebral body intra-operatively.The tip could not be retrieved because it broke off beneath the surface of the vertebral body.The procedure was completed successfully without surgical delay.No adverse consequences or medical intervention were reported.

• 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
• MDR Report Key: 11373796
• Report Number: 0009617544-2021-00023
• Device Sequence Number: 3630784
• Product Code: LXH
• UDI-Device Identifier: 07613327273038
• UDI-Public: 07613327273038
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/28/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1