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

Model Number	657312
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	06/26/2020
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 that two of the variax 2 locking screws would not lock into the plate.The screws would seat, a pop would be felt, and the screw spins freely.Variax 1 locking screws were used to complete the procedure successfully.There was no surgical delay.
Event or Problem Description
It was reported that two of the variax 2 locking screws would not lock into the plate.The screws would seat, a pop would be felt, and the screw spins freely.Variax 1 locking screws were used to complete the procedure successfully.There was no surgical delay.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and a surgery video was provided showing the alleged screws not locking with the plate.The visual inspection revealed no significant damage of returned device.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.Based on available information, no further action is required at this time.If any further information is provided, the complaint report will be updated.

• 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: 10305503
• Report Number: 0008031020-2020-01938
• Device Sequence Number: 2853809
• Product Code: HWC
• UDI-Device Identifier: 07613327086812
• UDI-Public: 07613327086812
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 10/27/2020

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: 657312
• Device Catalogue Number: 657312
• Device Lot Number: Y61007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR