MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FIBULA PLATE, 6 HOLE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	40-20906
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Ambulation or Postural Difficulties (2544)
Date of Event	01/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in (b)(6) 2021, the patient had a distal lateral fibula plate implanted to treat ankle orif.6-7 weeks post op the plate broke whilst in situ, impairing the function of the implant.On (b)(6) 2022, the patient had an additional surgery to remove the failed implant and underwent tibiotalarcalcaneal fusion.Additionally it was reported that the patient had fracture non union and the patients function was impaired.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that in (b)(6) 2021 the patient had a distal lateral fibula plate implanted to treat ankle orif.6-7 weeks post op the plate broke whilst in situ, impairing the function of the implant.On (b)(6) 2022 the patient had an additional surgery to remove the failed implant and underwent tibiotalarcalcaneal fusion.Additionally it was reported that the patient had fracture non union and the patients function was impaired.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the visual inspection of the screws and plate returned showed that the plate was indeed broken in two parts on the 7th hole from the distal part and that the 9 returned locking screws are intact and therefore concomitant.The identification of the device distal lateral fibula plate, 6 hole is confirmed based on the lot number and the catalog number marked.Signs of a fatigue fracture are visible with the microscopic analysis of the broken area, such as a fracture surface that is shiny and abraded.This is a result of the fragments (opposing bridges of the plate) rubbing against each for an extended period of time, before completely breaking due to fatigue and overloading.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 investigation, the root cause was attributed to a patient related issue.The failure was probably caused by repeated overloading of the plate.If any additional information is provided, the investigation will be reassessed.

• Brand Name: DISTAL LATERAL FIBULA PLATE, 6 HOLE
• Common Device Name: 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: 14913519
• Report Number: 0008031020-2022-00318
• Device Sequence Number: 6204372
• Product Code: KTT
• UDI-Device Identifier: 04546540567451
• UDI-Public: 04546540567451
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 40-20906
• Device Catalogue Number: 40-20906
• Device Lot Number: 1000406224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female