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

Model Number 657316

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was metal debris after removing the plate.

Manufacturer Narrative

Please note the correction made to the h6 component code: the reported event was confirmed.The device inspection revealed the following: heavy damage can be observed on the screw¿s tip, 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 for-mation of fragments.The slight decolorization and the wear observed on the bottom of the screw head give indi-cation 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.

Event Description

It was reported that there was metal debris after removing the plate.

• Brand Name: LOCKING 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: 15796156
• MDR Text Key: 307325049
• Report Number: 0008031020-2022-00607
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327086874
• UDI-Public: 07613327086874
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 657316
• Device Catalogue Number: 657316
• Device Lot Number: H33194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2021
• 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