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	05/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hospital retained the device.
Event or Problem Description
It was reported that an aviator temporary fixation pin snapped in half during insertion into the vertebral body.The procedure was completed successfully.
Event or Problem Description
It was reported that an aviator temporary fixation pin snapped in half during insertion into the vertebral body.The procedure was completed successfully.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, no adverse trends were identified.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.A root cause cannot be established with the information available.If additional information is received, the investigation will be reopened and updated.

• 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: 14658355
• Report Number: 0009617544-2022-00062
• Device Sequence Number: 3739768
• Product Code: LXH
• UDI-Device Identifier: 07613327273038
• UDI-Public: 07613327273038
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/07/2022

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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