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

Catalog Number 657320S

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device was discarded in hospital.

Event Description

It was reported that although the exterior variax elbow plate was fixed with locking screw, the screw was not locked.Therefore, the new same screw was inserted and the operation was finished.No surgical delay or adverse consequences were reported.

Event Description

It was reported that although the exterior variax elbow plate was fixed with locking screw, the screw was not locked.Therefore, the new same screw was inserted and the operation was finished.No surgical delay or adverse consequences were reported.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L20MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8482951
• MDR Text Key: 141345149
• Report Number: 0008031020-2019-00346
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327086942
• UDI-Public: 07613327086942
• 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: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 657320S
• Device Lot Number: Y35429
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR