MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L16MM; SCREW, FIXATION, BONE

Model Number 657416

Device Problem Material Fragmentation (1261)

Patient Problems Discomfort (2330); Foreign Body In Patient (2687)

Event Date 09/01/2022

Event Type  Injury  

Event 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.He reported the case to the head nurse and gave her all implants (plates + screws).

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

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 2nd thread was deformed in a downward direction as an upward force was exerted on the screw.The head of the screw was also damaged and deformed.The screw was most likely damaged during the extraction procedure.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 intraoperative misalignment 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 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 / L16MM
• Type of Device: 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: 16131215
• MDR Text Key: 308489036
• Report Number: 0008031020-2023-00013
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327073829
• UDI-Public: 07613327073829
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K180500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 657416
• Device Catalogue Number: 657416
• Device Lot Number: G31130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male