MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L20MM; SCREW, FIXATION, BONE

Model Number	657320S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2020
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
The customer reported that the thread on the screw came away as it was being inserted.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: some turns of the locking threads are indeed damaged / shaved off.Possible cause of these damages could have been as the locking screw was positioned on an unfavorable angle so that the material was getting shaved off.Based on investigation, the root cause was attributed to be user related.The failure was caused by possible inadequate angulation / positioning during screw insertion.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
The customer reported that the thread on the screw came away as it was being inserted.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L20MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10891922
• Report Number: 0008031020-2020-02520
• Device Sequence Number: 11536990
• Product Code: HWC
• UDI-Device Identifier: 07613327086942
• UDI-Public: 07613327086942
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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 Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2021

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: 01/31/2024
• Device Model Number: 657320S
• Device Catalogue Number: 657320S
• Device Lot Number: Y57985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1