MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FIBULA PLATE, 5 HOLE, STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number 40-20905S

Device Problem Material Fragmentation (1261)

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

Event Date 10/19/2022

Event Type  malfunction  

Event Description

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

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.The device inspection revealed the following: the identification of the returned plate was confirmed based on the catalog # and the lot # marked.Multiple scratches are visible on the plate surface as well as around the plate holes, which are intensively worn out.Metal debris from the plate are still visible on some holes.The wear around the holes give indication of possible misdrilling (non-use of the required drill guide), over-tightening of the screws and screws angulation outside the advised range (-15° to 15 °).These three factors are the probable causes of the metal debris observed.The scratches on the plate surface are probably due to explantation.Based on investigation, the root cause was attributed to a user related issue.The failure was most probably caused by mishandling when drilling and inserting the screws into the plate.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.¿ 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 dedicated 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 thevariax¿ foot locking screwmay 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 15°." 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: DISTAL LATERAL FIBULA PLATE, 5 HOLE, STERILE
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 15796085
• MDR Text Key: 307562901
• Report Number: 0008031020-2022-00601
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 04546540604637
• UDI-Public: 04546540604637
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K081284
• 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: 01/31/2023

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: 40-20905S
• Device Catalogue Number: 40-20905S
• Device Lot Number: 1000432821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2021
• 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