MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX BONE SCREW; IMPLANT

Catalog Number UNK_SEL

Device Problem Material Fragmentation (1261)

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

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported: "variax dr removal surgery.There was something like wire wrapped around the bone screw.".

Event Description

As reported: "variax dr removal surgery.There was something like wire wrapped around the bone screw.".

Manufacturer Narrative

The reported event could be confirmed.The device inspection shows that 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 a 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 inadequate handling of the device.A review of the device history was not possible because the device is not marked with identification and the lot number was not communicated.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.

• Brand Name: UNKNOWN VARIAX BONE SCREW
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10423188
• MDR Text Key: 204706658
• Report Number: 0008031020-2020-02181
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• 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 Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• 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