MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L34MM; SCREW, FIXATION, BONE

Catalog Number	657334
Medical Device Problem Codes	Material Erosion (1214); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that, during a primary procedure on a left foot, when driving the screw through the hole in the plate following the surgical technique, metal shavings were coming off the threads of the screw.The screw and shavings were removed.Another screw was inserted in the same hole of the plate and was able to be inserted with no metal shavings caused.Surgery was completed successfully with a delay of approximately 45 seconds.No adverse consequences reported.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by possible inappropriate positioning during screw insertion.The device inspection revealed the following: some metal abrasions are clearly visible only starting just a bit more then from the mid section onwards though.A close up of the front part of the thread shows that some metal swarf had been generated during screw insertion.The metal shaving has broken off and was not returned.These damages indicate that possibly inappropriate positioning during screw insertion (on an angle) has caused these abrasions.The screw head and its locking section are intact.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.If any further information is provided, the investigation report will be updated.
Event or Problem Description
It was reported that, during a primary procedure on a left foot, when driving the screw through the hole in the plate following the surgical technique, metal shavings were coming off the threads of the screw.The screw and shavings were removed.Another screw was inserted in the same hole of the plate and was able to be inserted with no metal shavings caused.Surgery was completed successfully with a delay of approximately 45 seconds.No adverse consequences reported.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L34MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8805228
• Report Number: 0008031020-2019-00903
• Device Sequence Number: 18946741
• Product Code: HWC
• UDI-Device Identifier: 07613327087192
• UDI-Public: 07613327087192
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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): 09/09/2019

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: 11/30/2023
• Device Catalogue Number: 657334
• Device Lot Number: Y56107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 09/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1