MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L18MM; SCREW, FIXATION, BONE

Model Number	657418
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received screw shows signs of usage as the threads of the screw were found deformed.The head of the screw was also damaged and deformed.The screw was most likely damaged during the implantation/extraction procedure.The analysis of the screws shows that the threads below the screw head for locking screws, and the threads along the shaft for the non locking screws are very deformed, with some material stripped away.This would be the origin of the reported metal spindles.  the material stripping is due to a combination of intraoperative misalignment and overtorque of some of the screws onto the plate during insertion which in turn caused stripping/fragmentation of the screw threads.  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 investigation, the root cause was attributed to a user-related issue.The revision of the plate and screws was most likely caused due to a combination of intraoperative misalignment and overtorque of some of the screws onto the plate during insertion which in turn caused stripping/fragmentation of the screw threads.This malalignment may have led to the alleged discomfort in subsequent days.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that during a variax clavicula plate removal, whilst removing the screws and plate the surgeon noticed some metal particles in the wound.Additional information: the reason for the removal of the plate was the discomfort it caused.There was no debris left in the patient.

• Brand Name: BONE SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L18MM
• 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: 16937828
• Report Number: 0008031020-2023-00197
• Device Sequence Number: 5730855
• Product Code: HWC
• UDI-Device Identifier: 07613327073850
• UDI-Public: 07613327073850
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 657418
• Device Catalogue Number: 657418
• Device Lot Number: Y51641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male