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

Catalog Number	657312S
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2019
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
As reported: "variax clavicle surgery was performed on (b)(6) 2019.When the surgeon tried to lock the locking screw to the hole of the plate, it did not lock.He exchanged the screw to the new one.The second screw was able to locked to the plate." procedure was completed successfully with no adverse consequence or surgical delay reported.
Additional Manufacturer Narrative
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 alignment of screw during insertion.Damage is consistent with abrasion against a hard material.Visual inspection of the returned device revealed severe damage to locking thread of locking screw.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: "variax clavicle surgery was performed on (b)(6) 2019.When the surgeon tried to lock the locking screw to the hole of the plate, it did not lock.He exchanged the screw to the new one.The second screw was able to locked to the plate." procedure was completed successfully with no adverse consequence or surgical delay reported.

• 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 ; CH 2545
• MDR Report Key: 9072948
• Report Number: 0008031020-2019-01278
• Device Sequence Number: 2616342
• 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
• Report Date (Section B): 10/17/2019

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 Catalogue Number: 657312S
• Device Lot Number: Y51702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR