MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW VARIAX FULL THREAD 3.5MM / L16MM; PLATE, FIXATION, BONE

Catalog Number	614816
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the following issue with the variax 3.5mm cortical screw occurred."the screw was inserted routinely into a clavicle plate.As it was screwed down to the plate, the screw head delaminated and the screw went right through the plate.It was reported that according to the user, no excess torque or angle was applied.It was reported that the user confirmed the correct 3.7mm drill bit was used during the procedure.
Additional Manufacturer Narrative
The reported event that bone screw variax full thread 3.5mm / l16mm was alleged of 'poor fixation' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by over-torquing the screw.When too much torque is applied during screw insertion, it can happen that the screw goes through the plate.The visual and microscopic inspection revealed marks of usage on the shaft and on head threads of the screw.Especially the proximal thread of the screw head is plastically damaged around, likely due to over-torque, when going through the plate.The damages found are typical when the surgeon is over-tightening the screw; the screw can go through the plate and the interface between the plate and the screw can deformed and damage the proximal thread of the screw head.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 any further information is provided, the investigation report will be updated.
Event or Problem Description
It was reported that the following issue with the variax 3.5mm cortical screw occurred."the screw was inserted routinely into a clavicle plate.As it was screwed down to the plate, the screw head delaminated and the screw went right through the plate.It was reported that according to the user, no excess torque or angle was applied.It was reported that the user confirmed the correct 3.7mm drill bit was used during the procedure.

• Brand Name: BONE SCREW VARIAX FULL THREAD 3.5MM / L16MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7805955
• Report Number: 0008031020-2018-00570
• Device Sequence Number: 11110763
• Product Code: HRS
• UDI-Device Identifier: 07613154970292
• UDI-Public: 07613154970292
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K101056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 614816
• Device Lot Number: V45102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other