MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L50MM; SCREW, FIXATION, BONE

Catalog Number	657350
Medical Device Problem Codes	Material Fragmentation (1261); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
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
As reported: "variax t10 screw metal in locking part of the screw head tear off during insertion.The screw was not fully tightened at the moment this happened.No excessive forces were used.".
Additional Manufacturer Narrative
Correction: please refer to h6 health impact code.The reported event could be confirmed during the inspection.The device inspection revealed the following: the identification of the returned screw could be confirmed based on the catalog # and lot # marked.The threads of the screw are worn out.The wear observed is a direct result of the insertion attempt and of the extraction following.Material loss on the threads of the screw head gives indication of unraveled material, confirming the reported event.Based on investigation, the root cause was attributed to a user related issue.Evidence of screw overtightening was observed, which should be avoided as it could damage the implant.As a reminder, the instructions for use clearly state that: "screws must not be over-tightened during insertion.Excessive overtightening will compromise the integrity of the screw head, resulting in possible screw breakage." 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 more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "variax t10 screw metal in locking part of the screw head tear off during insertion.The screw was not fully tightened at the moment this happened.No excessive forces were used.".

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L50MM
• 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: 20290043
• Report Number: 0008031020-2024-00498
• Device Sequence Number: 7199483
• Product Code: HWC
• UDI-Device Identifier: 07613327087383
• UDI-Public: (01)07613327087383(11)290131(17)240212(10)AF5914
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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: 657350
• Device Lot Number: AF5914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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