MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, T8 FULL THREAD, 2.4MM/L20MM; SCREW, FIXATION, BONE

Model Number	656020
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the distal radius variax 2 screws are fraying.
Event or Problem Description
It was reported that the distal radius variax 2 screws are fraying.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the locking threads on both locking screws are badly damaged / torqued / shaved off, some of the screw threads just below are also badly damaged.The most parts of the screw threads are still intact though.Which indicates that too much mechanical force had been applied only at the upper level of the locking screw during screw locking (final tightening).Both screws could not be locked anymore as the damages on the locking threads are too severe.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.Based on investigation, the root cause was attributed to be user related.The failure was caused by too much mechanical torque which applied during screw locking (possibly during inadequate tightening).If any further information is provided, the investigation report will be updated.

• Brand Name: LOCKING SCREW, T8 FULL THREAD, 2.4MM/L20MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9558911
• Report Number: 0008031020-2020-00097
• Device Sequence Number: 2245652
• Product Code: HWC
• UDI-Device Identifier: 07613327068375
• UDI-Public: 07613327068375
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/11/2020

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: 656020
• Device Catalogue Number: 656020
• Device Lot Number: 1000286844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1