MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 K-WIRE ASSY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	IS2739XLP02
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/11/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, the surgeon used the cannulated probe.The vertebral body of the patient bone sclerosis, so the surgeon hit the probe with a hammer.When the surgeon tried to pull out the internal probe k-wire, base of probe k-wire broke.The surgeon removed the broken probe k-wire.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment; the k-wire was examined visually and confirmed to be broken.A similar complaint involving a k-wire breakage resulted in the k-wire being sent for material analysis, which determined that the k-wire broke through ductile overload at multiple fracture initiation sites.Furthermore, no manufacturing defects were observed on the device features during this analysis.The reported k-wire breakage was likely due to cantilever forces contributing to an overload at the fracture site.
Event or Problem Description
It was reported that during the surgery, the surgeon used the cannulated probe.The vertebral body of the patient bone sclerosis, so the surgeon hit the probe with a hammer.When the surgeon tried to pull out the internal probe k-wire, base of probe k-wire broke.The surgeon removed the broken probe k-wire.

• Brand Name: XIA 3 K-WIRE ASSY
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5551957
• Report Number: 3004024955-2016-00039
• Device Sequence Number: 19075909
• Product Code: LXH
• UDI-Device Identifier: 07613327279344
• UDI-Public: (01)07613327279344
• Combination Product (Y/N): N
• 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): 03/11/2016

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: IS2739XLP02
• Device Lot Number: 21169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2016
• Supplement Report FDA Received Date: 07/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR