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

Catalog Number	48770410
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the temporary fixation pin tip broke off during insertion.Surgeon was able to get remove broken tip.No adverse consequences to the patient is reported.
Event or Problem Description
It was reported that the temporary fixation pin tip broke off during insertion.Surgeon was able to get remove broken tip.No adverse consequences to the patient is reported.
Additional Manufacturer Narrative
Visual inspection, material analysis, product history review, complaint history review, nc/capa history review, labelling review.The reported event was confirmed upon visual inspection.Material analysis was performed and found that the device was found to have fractured in a mode of torsional ductile overload.The elemental constitution was as specified on the drawing.No material or manufacturing defects were found.Manufacturing history was reviewed and no anomalies were found.The hard bone quality may cause a material overload as it is difficult to advance into the bone or a previously used fixation pin may have been previously damaged.Conclusion: the potential root causes include: hard bone quality, fixation pin is previously used.However, the exact cause cannot be determined.

• Brand Name: AVIATOR TEMPORARY FIXATION PIN
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7831421
• Report Number: 0009617544-2018-00210
• Device Sequence Number: 1175709
• Product Code: KWQ
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2018

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 Catalogue Number: 48770410
• Device Lot Number: X46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1