MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FIBULA PLATE, 7 HOLE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	40-20907
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	08/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the doctor was revising an ankle orif.The variax distal fibula plate was not originally coming out but the doctor noticed that the plate was broken.He felt like the plate broke in an usual place.He took the plate and screws out and added a longer variax distal fibula plate.
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 the doctor was revising an ankle orif.The variax distal fibula plate was not originally coming out but the doctor noticed that the plate was broken.He felt like the plate broke in an usual place.He took the plate and screws out and added a longer variax distal fibula plate.
Additional 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 plate is broken from the proximal holes.The holes along the shaft of the plate have deformed threads suggestive of application of cyclic overloading.The pattern on the broken surfaces elicits fatigue fracture.In addition to this, the holes in the distal part of the plate are deformed which suggests cyclic overloading as well.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 caused by repeated overloading of the plate.Patient's bmi is most likely one the contributing factors.Patient details: age- 63 years.Height- 73 inches/ 6'1".Weight- 235 pounds / 106 kg.Bmi- 30.8.If any further information is provided, the complaint report will be updated.

• Brand Name: DISTAL LATERAL FIBULA PLATE, 7 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: 15422123
• Report Number: 0008031020-2022-00439
• Device Sequence Number: 6722328
• Product Code: KTT
• UDI-Device Identifier: 04546540567468
• UDI-Public: 04546540567468
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K081284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2023

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: 40-20907
• Device Catalogue Number: 40-20907
• Device Lot Number: 1000316171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2022
• Supplement Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2018
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 107 KG