MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FIBULA PLATE, 3 HOLE, STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 40-20903S

Device Problem Material Fragmentation (1261)

Patient Problems Failure of Implant (1924); Inflammation (1932); Foreign Body In Patient (2687); Swelling/ Edema (4577)

Event Date 10/25/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on 28 apr 2021 the patient had primary surgery and a fibular plate and screws were inserted.The plate and screws were extracted on 01 jun 2022 due to completed bone union.On (b)(6) 2023 the patient was seen in the outpatient clinic because of the appearance of an inflammatory reaction.The affected area had started to swell a little around january and then the bulge in the affected area grew larger.A metal shard-like substance was removed from the surgical wound through a small incision.

Event Description

It was reported that on (b)(6) 2021 the patient had primary surgery and a fibular plate and screws were inserted.The plate and screws were extracted on (b)(6) 2022 due to completed bone union.On (b)(6) 2023 the patient was seen in the outpatient clinic because of the appearance of an inflammatory reaction.The affected area had started to swell a little around (b)(6) and then the bulge in the affected area grew larger.A metal shard-like substance was removed from the surgical wound through a small incision.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Only a part of a ripped off thread was returned.However, it could not be possible to determine if the fragment is from one of the reported screws or from the plate.The fragment does not enable a detailed investigation.The root cause of the reported event could not be determined.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 the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition unknown.

• Brand Name: DISTAL LATERAL FIBULA PLATE, 3 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: 18219238
• MDR Text Key: 329148005
• Report Number: 0008031020-2023-00411
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 04546540604613
• UDI-Public: 04546540604613
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 40-20903S
• Device Lot Number: 1000422777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2020
• 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 Sex: Female