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

Catalog Number	48230231
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	04/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported mis-tlif was done at l4/l5/s1.After the screw was inserting to right l5 over k wire with power tool, the k wire was not able to be removed.Therefore, it was removed with pliers.After that, the surgeon confirmed the tip of the k wire was left in vertebral body under x-p.Finally, the new screw was inserted and the operation was finished.No adverse consequences to the patient is reported.
Additional Manufacturer Narrative
Method: visual inspection, labelling review, risk assessment.Results: the returned device was confirmed to be fractured.The fractured surfaced was viewed under a microscope - spiral fracture was observed indicating that the wire may have fractured due to torsion/twisting.A valid lot# was not provided nor could it be retrieved from the returned device, therefore device history review and complaint history review could not be performed.Conclusion: the likely cause of device fracture is due to excessive torsional force applied during insertion.
Event or Problem Description
It was reported mis-tlif was done at l4/l5/s1.After the screw was inserting to right l5 over k wire with power tool, the k wire was not able to be removed.Therefore, it was removed with pliers.After that, the surgeon confirmed the tip of the k wire was left in vertebral body under x-p.Finally, the new screw was inserted and the operation was finished.No adverse consequences to the patient is reported.

• Brand Name: XIA PRECISION K WIRE BLUNT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7483101
• Report Number: 0009617544-2018-00104
• Device Sequence Number: 13850987
• Product Code: LXH
• UDI-Device Identifier: 07613327265286
• UDI-Public: (01)07613327265286
• 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): 08/22/2018

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: 48230231
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 80