MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L24MM; SCREW, FIXATION, BONE

Model Number 657324

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

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Intraoperative detection of inadequate screw retention with considerable formation of metal splinters.

Event Description

Intraoperative detection of inadequate screw retention with considerable formation of metal splinters.

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 approximately 6 threads at distal.A metal splinter/wire was also received which most likely emerged from the distal end and moved towards proximal as the screw was pushed inside.The threads at the proximal end, just underneath the head were also 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.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L24MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10474755
• MDR Text Key: 205308963
• Report Number: 0008031020-2020-02197
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327086980
• UDI-Public: 07613327086980
• Combination Product (y/n): N
• PMA/PMN Number: K180500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 657324
• Device Catalogue Number: 657324
• Device Lot Number: Y51690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR