MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L10MM; SCREW, FIXATION, BONE

Model Number	657310
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	06/18/2020
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
It was reported: there was no locking in the plate with several variax2 locking screws 10mm 3.5 t10.The procedure was successfully completed by removing the affected screws and using variax1 screws instead.Surgical delay of 20min.Not longer.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was returned for evaluation and is functional.The device was returned and does not present any visible damage to the threads which could have lead to an inability to screw with the plate.A functional test was performed by screwing the returned screw with a variax plate, and the device was able to lock with no issue, in various screw holes.The event can therefore not be confirmed.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: there was no locking in the plate with several variax2 locking screws 10mm 3.5 t10.The procedure was successfully completed by removing the affected screws and using variax1 screws instead.Surgical delay of 20min.Not longer.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L10MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10278302
• Report Number: 0008031020-2020-01909
• Device Sequence Number: 2865261
• Product Code: HWC
• UDI-Device Identifier: 07613327086782
• UDI-Public: 07613327086782
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020

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 Expiration Date: 10/31/2024
• Device Model Number: 657310
• Device Catalogue Number: 657310
• Device Lot Number: D54942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1