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

Model Number 657316S

Device Problems Positioning Failure (1158); Material Fragmentation (1261)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

As reported: "during the initial operation on (b)(6) 2020, the locking screw did not lock to the plate.So, the screw was removed.When it was pulled out, thread-shaped metal pieces [.] was found.After screw was exchanged with new one, it was able to lock without problem.".

Manufacturer Narrative

The reported event could be confirmed.The device inspection revealed the following: the pictures provided confirm the reported event: a metallic wire of what looks like the thread under the screw head has detached from the screw.This is most probably the result of the application of an inappropriate angulation during the insertion of the screw, paired with significant force.The combination of these two factors could have resulted in the shearing of the screw threads against the plate, resulting in the metallic wire.Based on investigation, the root cause was attributed to be user related.The failure was caused by an inadequate handling of the 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.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 Description

As reported: "during the initial operation on (b)(6) 2020, the locking screw did not lock to the plate.So, the screw was removed.When it was pulled out, thread-shaped metal pieces [.] was found.After screw was exchanged with new one, it was able to lock without problem.".

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L16MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10423136
• MDR Text Key: 203497389
• Report Number: 0008031020-2020-02177
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327086881
• UDI-Public: 07613327086881
• Combination Product (y/n): N
• PMA/PMN Number: K132502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

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
• Device Operator: Health Professional
• Device Model Number: 657316S
• Device Catalogue Number: 657316S
• Device Lot Number: G21680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 09/24/2020
• Supplement Dates FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1