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

Model Number	657316
Medical Device Problem Codes	Positioning Failure (1158); Material Fragmentation (1261)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	08/03/2020
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
Intraoperative detection of inadequate screw retention with considerable formation of metal splinters.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the received screw was found to be damaged around the threads at the proximal and slightly at the distal most end.A metal splinter/wire was also received which most likely emerged from the proximal end, just underneath the head, as a result of overtightening.The area was severely damaged and deformed plastically.These damages and wire formation indicates towards excessive force that was applied to screw in the screw with some misalignment/angulation as well.Although, a small metal wire was sent back but it wasn¿t confirmed whether all the metal debris was removed from the patient.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the root cause of the failure is determined to be user related.There was a definite overtightening and misalignment of the screw involved as observed through the deformation and stripping in the returned screw.Based on available information, no further action is required at this time.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Intraoperative detection of inadequate screw retention with considerable formation of metal splinters.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L16MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10474737
• Report Number: 0008031020-2020-02198
• Device Sequence Number: 2147020
• Product Code: HWC
• UDI-Device Identifier: 07613327086874
• UDI-Public: 07613327086874
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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: 657316
• Device Catalogue Number: 657316
• Device Lot Number: G25450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR