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

Model Number	657438
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "a straight plate of the variax foot system was required for a reduction of the distal tibia and at the time of placing the screws to fix it, they went through the holes of the plate displacing the plate and it had to be removed and it was needed to find another way to maintain the reduction increasing the surgical time.".
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: "a straight plate of the variax foot system was required for a reduction of the distal tibia and at the time of placing the screws to fix it, they went through the holes of the plate displacing the plate and it had to be removed and it was needed to find another way to maintain the reduction increasing the surgical time.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was returned and found to be fully functional.Device inspection revealed the following: the received bone screw was visually inspected in which we can see the damaged head the shape of the screw head is clearly damaged, which is caused by misalignment and application of excessive force which can be implantation or explantation.A functional test was conducted with the received plate and screws in which we were able to assemble them properly.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.Based on the investigation root cause can be attributed to user-related.If any additional information is provided, the investigation will be reassessed.

• Brand Name: BONE 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: 17054715
• Report Number: 0008031020-2023-00212
• Device Sequence Number: 6814594
• Product Code: HWC
• UDI-Device Identifier: 07613327074116
• UDI-Public: 07613327074116
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2023

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: 657438
• Device Catalogue Number: 657438
• Device Lot Number: H32560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 24 YR
• Patient Sex: Male
• Patient Weight: 72 KG