MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L14MM; SCREW, FIXATION, BONE

Catalog Number	657314
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported a locking screw was inserted into the distal locking hole, but it was unable to lock and was spinning, and a small piece of metal was seen (whether it was the plate side or the screw side).The hole could not be used, and the other screw was used in the other hole, but it was still idle and could not be locked.After that, when a new screw was used, locking was possible without issue.
Event or Problem Description
It was reported a locking screw was inserted into the distal locking hole, but it was unable to lock and was spinning, and a small piece of metal was seen (whether it was the plate side or the screw side).The hole could not be used, and the other screw was used in the other hole, but it was still idle and could not be locked.After that, when a new screw was used, locking was possible without issue.
Additional Manufacturer Narrative
The reported event could be confirmed, since visual inspection reveals severely damaged locking thread on screw.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Additional information provided in complaint states that ¿a small piece of metal was seen (whether it was the plate side or the screw side)¿.The ¿small piece of metal¿ referred to was not returned.Based on investigation results, the root cause was attributed to a user related issue.The failure was caused by over-torqueing the screw during insertion.The optech information provides the below user instructions: ¿during bone screw insertion in an oblong hole, the surgeon should rely on tactile feedback to prevent excessive torque which may result in thread/bone stripping, screw damage/pull through, or screwdriver damage.Proper observation of bone quality, screw size, and instrumentation can help determine the appropriate insertion torque during insertion and final tightening of the screw in the plate.When the screw is fully seated during final tightening, an increase of resistance indicates sufficient screw fixation.If any further information is provided, the complaint report will be updated.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L14MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9323877
• Report Number: 0008031020-2019-01672
• Device Sequence Number: 2223936
• Product Code: HWC
• UDI-Device Identifier: 07613327086843
• UDI-Public: 07613327086843
• Combination Product (Y/N): N
• PMA/510(K) Number: K180500
• 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): 12/30/2019

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: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 657314
• Device Lot Number: D33138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 12/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR