MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L16MM; PLATE, FIXATION, BONE

Catalog Number	657316S
Medical Device Problem Codes	Material Fragmentation (1261); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: ''orif was performed for left distal fibula fracture (primary surgery date is unknown).During the bariatric fibula explanting surgery on (b)(6) 2024, something like metal shavings came out while removing the bone surrounding the screw head." no further information has been provided.
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 based on the inspection performed.The device inspection revealed the following: the identification of the locking screw was confirmed based on the catalog number and lot number marked.The screws show signs of unraveled thread, which occurred at the threaded part below the head.This is most probably a result of over torque being applied during screw insertion, with an angulation outside of the range advised (negative fifteen to fifteen).Pictures taken during the explantation were received for the inspection and confirm the observations made during the device¿s inspection.As a reminder, the operative technique clearly states that: during bone screw insertion in an oblong hole, the surgeon should rely on tactile feedback to prevent excessive torque which may result in thread, bone stripping, screw damage, pull through or screwdriver damage.Proper observation of bone quality, screw size and instrumentation can help decide the proper insertion torque during insertion and final tightening of the screw in the plate.When the screw is fully seated during final tightening, an increase of resistance shows sufficient screw fixation.The instructions for use clearly state that: when engaging a screwdriver blade within a screw head, the blade must be fully seated within the head of the screw.Placement of all screws requires the use of a resolute drill guide to ensure proper screw placement.If a drill guide is not used, the plate may be damaged, and the screw may not lock into the plate.Excessive tightening of the variax foot locking screw may lead to titanium particle generation.Particles must be removed to prevent potential contamination causing inflammation.The angle of the inserted variax foot locking screw must not exceed fifteen.Based on the investigation, the root cause was attributed to a user related issue.The failure was most probably caused by over torque applied during the locking screws insertion, with an unadvised angulation.A review of the device history for the reported lot did not show any abnormalities.No corrective actions are needed currently.A review of the labeling did not show 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: ''orif was performed for left distal fibula fracture (primary surgery date is unknown).During the bariatric fibula explanting surgery on (b)(6) 2024, something like metal shavings came out while removing the bone surrounding the screw head.".No further information has been provided.

• Brand Name: LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L16MM
• Common Device Name: PLATE, 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: 19068008
• Report Number: 0008031020-2024-00155
• Device Sequence Number: 4658779
• Product Code: HRS
• UDI-Device Identifier: 07613327086881
• UDI-Public: 07613327086881
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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: Lay User/Patient
• Device Catalogue Number: 657316S
• Device Lot Number: K68307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• 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: Prefer Not To Disclose