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

Catalog Number	48230231
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during (l4/5, l5/s1 mis-plif) surgery, a progress of a screw has stopped when the surgeon was inserting the screw to l4 left through a k-wire.The k-wire did not be removed from the screw, so the surgeon removed the k-wire and the screw together.Then, the surgeon inserted the other screw through the other k-wire.
Additional Manufacturer Narrative
Lot# b63292.Device inspection, functional analysis, device history review, complaint history review, risk assessment.The k wire was returned in a deformed condition.The k wire was severly bent overall and had several smaller bends throughout the wire.The k wire was attempted to be passed through the screw cannula and was unable to when it reached the bent portion.No relevant manufacturing issues found upon device history review.According to the risk file, some of the potential causes which lead to such type of jamming are: previously damaged or deformed screwdriver cannula, - k-wire was bent or damaged during a previous step, - burrs on k-wire, - user error, user does not align crew and screwdriver to k-wire.The probable root cause of the reported jamming is due to the bent/deformed k-wire.
Event or Problem Description
It was reported that; during (l4/5, l5/s1 mis-plif) surgery, a progress of a screw has stopped when the surgeon was inserting the screw to l4 left through a k-wire.The k-wire did not be removed from the screw, so the surgeon removed the k-wire and the screw together.Then, the surgeon inserted the other screw through the other k-wire.

• Brand Name: XIA PRECISION K WIRE BLUNT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5821841
• Report Number: 0009617544-2016-00303
• Device Sequence Number: 878460
• 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
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2016

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: 48230231
• Device Lot Number: B63292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2016
• Supplement Report FDA Received Date: 11/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR