MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L16MM; PLATE, FIXATION, BONE

Model Number	657316S
Medical Device Problem Codes	Positioning Failure (1158); Failure to Advance (2524)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2020
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: locking plate and locking screw did not lock.The screw was replaced with other one, and able to lock with the plate.The lot # of the screw which did not lock is unknown but the reporter requested to investigate if locking was unsuccessful with the same lot (3 of them).
Additional Manufacturer Narrative
Correction: refer to h6 device code.The reported event that locking screw variax2 t10, full thread, 3.5mm / l16mm was alleged of 'implant - assembling / disassembling impaired' could not be confirmed, since the returned device is conforming to specifications and fully 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 made by screwing the returned screw with a random variax plate, and the device was able to lock with no problem, 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: locking plate and locking screw did not lock.The screw was replaced with other one, and able to lock with the plate.The lot # of the screw which did not lock is unknown but the reporter requested to investigate if locking was unsuccessful with the same lot (3 of them).

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L16MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10261165
• Report Number: 0008031020-2020-01882
• Device Sequence Number: 11419027
• Product Code: HRS
• UDI-Device Identifier: 07613327086881
• UDI-Public: 07613327086881
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2020

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: 12/31/2024
• Device Model Number: 657316S
• Device Catalogue Number: 657316S
• Device Lot Number: D61274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2020
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1