MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L14MM; PLATE, FIXATION, BONE

Model Number 657314S

Device Problem Material Fragmentation (1261)

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

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A piece of metal that was as if peeled off from the screw was found.Replaced with another screw.

Manufacturer Narrative

The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received screw was found to be carrying a wire formed due to stripping of the screw.The wire formation started approximately from the 3rd thread from the distal end and moved towards proximal as the screw was pushed inside.The flat nature of the wire and the deformed threads, and the also non-uniform markings on the head of the screw indicates towards excessive force that was applied to screw in the screw with some mis-alignment as well.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.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.If any additional information is provided, the investigation will be reassessed.

Event Description

A piece of metal that was as if peeled off from the screw was found.Replaced with another screw.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L14MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10379935
• MDR Text Key: 202069054
• Report Number: 0008031020-2020-02101
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327086850
• UDI-Public: 07613327086850
• Combination Product (y/n): N
• PMA/PMN Number: K132502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• 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: 657314S
• Device Catalogue Number: 657314S
• Device Lot Number: G26113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 08/07/2020
• 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