MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, T10 FULL THREAD, 2.7MM/L16MM; SCREW, FIXATION, BONE

Catalog Number	657016
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "during surgery today, the doctor decided to place a lateral fibula plate.The procedure started with the placement of the most distal screws.The doctor chose to use 2.7 mm locking screws, so the assistant provided the 2.0 mm drill and the corresponding guide.When attempting to place the screws, none of the three locked.The assistant suggested that the doctor orient the screws in a different direction.With this adjustment, two of the screws successfully locked, but the third one did not lock in any direction the doctor tried".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence in the form of medical records and images were provided.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.More detailed information about the complaint event in terms of medical records such as x-rays as well as the affected device must be available in order to determine the root cause of the complaint event.Related to the reported failure mode regarding the locking of the variax2 screw it can be mentioned that as part of our post market surveillance activities a potential non-conformity report was initiated to address similar events related to the variaax2 locking feature.The deep investigation of the nc revealed that the application of over torque during insertion was the root cause of the event.This leads to the damage of the smart lock technology below the head.Also, the operative technique and the instructions for use provide some key information with respect to screw insertion: the elongated oblong hole is designed to assist in allowing flexibility with plate placement.A non-locking screw can be initially placed through the hole, allowing for some stability until the ideal plate placement is determined.This hole will not accept a locking screw.The drill guide is designed to limit drilling to a plus 15 or minus 15 degrees angle with respect to the plate.Drilling at an angle greater than plus 15 or minus 15 degrees may prevent locking from taking place and should be avoided.Although the locking and non-locking screws found in the variax 2 system are self-tapping, when encountering hard bone a tap may be required.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "during surgery today, the doctor decided to place a lateral fibula plate.The procedure started with the placement of the most distal screws.The doctor chose to use 2.7 mm locking screws, so the assistant provided the 2.0 mm drill and the corresponding guide.When attempting to place the screws, none of the three locked.The assistant suggested that the doctor orient the screws in a different direction.With this adjustment, two of the screws successfully locked, but the third one did not lock in any direction the doctor tried.".

• Brand Name: LOCKING SCREW, T10 FULL THREAD, 2.7MM/L16MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20030954
• Report Number: 0008031020-2024-00330
• Device Sequence Number: 3035481
• Product Code: HWC
• UDI-Device Identifier: 07613327069297
• UDI-Public: (01)07613327069297(10)1000417879
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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: Health Professional
• Device Catalogue Number: 657016
• Device Lot Number: 1000417879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2020
• 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