MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM POLYAXIAL SCREWDRIVER LONG; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	482391330L
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that dr.Placed 9.5x50 screw in left s1 pedicle during revision surgery.Dr was replacing current 8.5 diameter screw with larger due to having a 'loose feel'.Upon placement, dr wanted to remove and redirect due to 'poor' trajectory, but could not.Dr.Broke handle/driver/nut trying to remove with primary driver, then switch to lumbar removal driver over a locked down piece of rod with blocker to top of tulip to try to 'helicopter' screw out since it was so stuck.During process of trying to remove, he broke tulip/ head off of screw off of main screw shaft.Dr could not remove remainder of broken screw from patient with lumbar removal set - so he left it in place due to not having effect pm patient's outcome and moved on with case.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment; the device was inspected and it was found that the sleeve wing tips were fractured off of the device.The teeth on the sleeve are also deformed.No relevant manufacturing issues were identified as all units met specifications.The most likely root cause is excessive force was applied to the driver causing it to fracture, with incorrect trajectory of the screw also contributing to the event.
Event or Problem Description
It was reported thatl doctor placed 9.5x50 screw in left s1 pedicle during revision surgery.Doctor was replacing current 8.5 diameter screw with larger due to having a 'loose feel'.Upon placement, doctor wanted to removed and redirect due to 'poor' trajectory, but could not.Doctor broke handle/driver/nut trying to remove with primary driver, then switch to lumbar removal driver over a locked dowm piece of rod with blocker to top of tulip to try to 'helicopter' screw out since it was so stuck.During process of trying to remove, he broketulip/head off of screw off of main screw shaft.Doctor could not remove remainder of brokem screw from patient with lumbar removsl set - so he left it in place due to not having effect pm patient's outcome and moved on with case.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREWDRIVER LONG
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6524012
• Report Number: 0009617544-2017-00177
• Device Sequence Number: 687405
• Product Code: LXH
• UDI-Device Identifier: 07613327276701
• UDI-Public: (01)07613327276701
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2017

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: 482391330L
• Device Lot Number: 114304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 06/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1