MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L10MM; PLATE, FIXATION, BONE

Model Number 657310S

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

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported: when the locking screw was inserted into the plate, the screw thread was scraped and it could not be locked.Collect the screw and debris.The surgeon inserted a new screw and finished the operation successfully.

Event Description

It was reported: when the locking screw was inserted into the plate, the screw thread was scraped and it could not be locked.Collect the screw and debris.The surgeon inserted a new screw and finished the operation successfully.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.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 material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More information as well as the affected device must be available in order to determine the exact root cause of the failure.However, based on past complaint history some of the probable causes could be, but not limited to: overtightening of the screw, insertion of the screw in an inadequate angle etc.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 / L10MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10311168
• MDR Text Key: 199990561
• Report Number: 0008031020-2020-01946
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327086799
• UDI-Public: 07613327086799
• 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: 10/20/2020

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 Expiration Date: 11/30/2023
• Device Model Number: 657310S
• Device Catalogue Number: 657310S
• Device Lot Number: Y54933
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 09/24/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR