MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L22MM; SCREW, FIXATION, BONE

Model Number	657322
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the following issue: "the materialovigilance declaration has not yet been made by the surgeon, it seems that there was a problem with the screw thread and that there was a spark with a visible flame when the drill was inserted." update - 2/21/2022: the procedure could be completed correctly by opening the clavicle ancillary to recover the screw racks of the same size.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the affected device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: during the visual inspection of the returned device, it is noted that the crest of the thread flank has separated/has sheared off under significant force which shows plastic deformation (metal chip generation) which can be attributed to improper insertion of the variax screw into the plate.The screw is inserted at an angle that is too big or too close to the lip of the plate, and this generates friction between the two metals, leading to a stripping of the screw.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 user-related which can be attributed towards improper insertion of the variax screw into the plate.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reported the following issue: "the materialovigilance declaration has not yet been made by the surgeon, it seems that there was a problem with the screw thread and that there was a spark with a visible flame when the drill was inserted." update - (b)(6) 2022: the procedure could be completed correctly by opening the clavicle ancillary to recover the screw racks of the same size.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L22MM
• 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: 13743337
• Report Number: 0008031020-2022-00101
• Device Sequence Number: 20076353
• Product Code: HWC
• UDI-Device Identifier: 07613327086959
• UDI-Public: 07613327086959
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2022

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: 657322
• Device Catalogue Number: 657322
• Device Lot Number: G36990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 03/12/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2020
• 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: Unknown