MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FIBULA PLATE, 4 HOLE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	40-20904
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Discomfort (2330)
Date of Event	12/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "the first surgery was performed on (b)(6) 2020.At this time, the soft tissue was in poor condition, and the procedure was completed with only the distal anterolateral plate of the axsos tibia, and then the variax fibula was applied on (b)(6).After 4 weeks of unloading, we started to apply weight, and at 6th week we started full weighting, and at 7th week the patient felt uncomfortable.The revision was made on (b)(6).Only axsos and asnis were removed, and variax was not completely broken, so it was left as it was.Since the condition of the soft tissue was still poor, the operation was completed with vac after wearing external fixation.".
Additional Manufacturer Narrative
Correction: refer to d9/h3 device availability, h6 results & conclusion codes.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.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 is unknown.
Event or Problem Description
As reported: "the first surgery was performed on (b)(6), 2020.At this time, the soft tissue was in poor condition, and the procedure was completed with only the distal anterolateral plate of the axsos tibia, and then the variax fibula was applied on (b)(6),.After 4 weeks of unloading, we started to apply weight, and at 6th week we started full weighting, and at 7th week the patient felt uncomfortable.The revision was made on december 9th.Only axsos and asnis were removed, and variax was not completely broken, so it was left as it was.Since the condition of the soft tissue was still poor, the operation was completed with vac after wearing external fixation.".

• Brand Name: DISTAL LATERAL FIBULA PLATE, 4 HOLE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11121143
• Report Number: 0008031020-2021-00003
• Device Sequence Number: 3595699
• Product Code: KTT
• UDI-Device Identifier: 04546540567437
• UDI-Public: 04546540567437
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2021

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: 40-20904
• Device Catalogue Number: 40-20904
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR