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

Model Number	657422
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
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 there was metal debris after removing the plate.
Event or Problem Description
It was reported that there was metal debris after removing the plate.
Additional Manufacturer Narrative
Please note the correction to the h6 device code: the reported event was confirmed.The device inspection revealed the following: the head of the returned screw is heavily worn out, especially on the inside.The wear observed is due to normal implantation and explantation but can also be related to a possible overtightening of the screw on the plate.The thread is heavily damaged, most probably due to explantation, but also to a possible excessive angulation of the screw, out of the advised range (-15° to 15°) during insertion.The damage observed led to the formation of fragments.The slight decolorization and the wear observed on the bottom of the screw head give indication that the screw was overtightened on the plate.Based on investigation, the root cause was attributed to a user related issue.Evidence of screw overtightening and unadvised screw angulation were 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.

• Brand Name: BONE 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: 15797463
• Report Number: 0008031020-2022-00611
• Device Sequence Number: 4754600
• Product Code: HWC
• UDI-Device Identifier: 07613327073911
• UDI-Public: 07613327073911
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

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: 657422
• Device Catalogue Number: 657422
• Device Lot Number: G45110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2020
• 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