MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L38MM; SCREW, FIXATION, BONE

Model Number	657338
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2022
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 as the screw progressed, it would not engage the locking mechanism.It was further reported that it spun freely losing all compression on the bone.A surgical delay of 45-minutes was reported.
Event or Problem Description
It was reported that as the screw progressed, it would not engage the locking mechanism.It was further reported that it spun freely losing all compression on the bone.A surgical delay of 45-minutes was reported.
Additional Manufacturer Narrative
The reported event could be confirmed, since the screw locking feature in some of the plate holes is not given anymore.The device inspection revealed the following: the visual inspection has shown that the thread flanks of the locking thread are in a good condition, while the t10 recess shows some marks and deformations from forcible use.A function test with the received locking screws and the just slightly damaged screw holes of the received plate was made.It was possible to lock all three locking screws in these holes, no functional issue of the locking screws could be detected when the screws were placed in a intact hole.In the outer, strongly deformed, holes a locking of the screws was not possible anymore due to the extensive damages at the plate holes.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.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by an extreme insertion angle of the screws, this did lead to an undue contact between the screws and the plate.This contact caused a strong deformation of the locking holes at the plate.This deformation made finally a locking of a screw impossible, regardless if the insertion angle was afterwards adapted or a new screw was used.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L38MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15712792
• Report Number: 0008031020-2022-00567
• Device Sequence Number: 6619658
• Product Code: HWC
• UDI-Device Identifier: 07613327087161
• UDI-Public: 07613327087161
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2022

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 Model Number: 657338
• Device Catalogue Number: 657338
• Device Lot Number: Y54937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 11/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female