MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM; SCREW, FIXATION, BONE

Model Number	657312S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2020
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
As reported: "in the variax fibra operation the proximal screw did not lock to the plate.The screw was idling.The angle to the plate was not steep and the screw of 12mm was inserted for the 14mm measurement, and thus drill was enough.The wound was closed without inserting another screw.".
Additional Manufacturer Narrative
Correction: section d4 (lot #).The originally reported lot # could not be found in stryker's database.Therefore, no information regarding the manufacturing is available at this time.Due to the current covid-19 pandemic, it was not possible to evaluate the device as access to the facility is restricted.The investigation will be reassessed as soon as the restriction is lifted.A review of the labeling did not indicate any abnormalities.
Event or Problem Description
As reported: "in the variax fibra operation the proximal screw did not lock to the plate.The screw was idling.The angle to the plate was not steep and the screw of 12mm was inserted for the 14mm measurement, and thus drill was enough.The wound was closed without inserting another screw.".
Additional Manufacturer Narrative
Correction: sections d4 (lot # - the lot # in the initial report was correct), d9, h3.The reported event could be confirmed, since the locking screw was returned severely damaged at the locking thread.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by inadequate handling of the screw during insertion.Damage is consistent with abrasion against a hard material.The device inspection reveals severe damage to locking thread of locking screw.Therefore, this case is classified as a user related issue.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 complaint report will be updated.
Event or Problem Description
As reported: "in the variax fibra operation the proximal screw did not lock to the plate.The screw was idling.The angle to the plate was not steep and the screw of 12mm was inserted for the 14mm measurement, and thus drill was enough.The wound was closed without inserting another screw.".

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 9984150
• Report Number: 0008031020-2020-01389
• Device Sequence Number: 4442212
• Product Code: HWC
• UDI-Device Identifier: 07613327086829
• UDI-Public: 07613327086829
• Combination Product (Y/N): N
• PMA/510(K) Number: K132502
• 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,Followup
• Report Date (Section B): 11/16/2020

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 Model Number: 657312S
• Device Catalogue Number: 657312S
• Device Lot Number: D61049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 06/11/2020; 10/22/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 07/08/2020; 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR