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

Catalog Number	IS2739XLP02
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
K-wire fractured during surgery.No adverse consequences were reported.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment.Result: the customer reported event was confirmed via visual inspection.All broken fragments were retrieved and surgery was completed successfully.The assembly was returned in 3 pieces.The inner shaft was fractured in 2, with the knob fractured off of the main shaft.The device shows signs of wear and tear.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The device was manufactured in 2012, making it 6 years old at the time of the event.The device was found to be 6 years old and showed signs of wear and tear.The instruments ifu states "the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order." conclusion: the most likely root cause is wear from the device's extended use.The patient's hard bone quality also most likely contributed to the event as this would have put extra stress on the device while being impacted.
Event or Problem Description
K-wire fractured during surgery.No adverse consequences were reported.

• 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: 7931302
• Report Number: 3004024955-2018-00047
• Device Sequence Number: 11088135
• Product Code: LXH
• UDI-Device Identifier: 07613327279344
• UDI-Public: 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): 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: IS2739XLP02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 10/03/2018
• 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
• Patient Age: 21 YR