MAUDE Adverse Event Report: STRYKER GMBH FOOT RING LONG HOFFMANN LRF 180MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	4934-4-180
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/21/2020
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: "180mm carbon fiber foot plate long snapped when patient was walking on it.We had to go back for surgery a week later.Patient should recover just fine, but had to be put under anesthesia again.".
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by a mishandling of the device.The review of device history for the reported lot did not indicate any abnormalities.Moreover, no indications of material, manufacturing or design related problems were found during the investigation.Therefore, the device broke when subjected to high load.The ifu states that "if the patient¿s activity comprises significant impact loads (walking, running, lifting or turning) the resulting forces could lead to failure of the fixation, the system or both.The system will not restore function to the level expected with normal healthy bone, and the patient should not have unrealistic functional expectations." this case is then classified as a user related issue.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.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "180mm carbon fiber foot plate long snapped when patient was walking on it.We had to go back for surgery a week later.Patient should recover just fine, but had to be put under anesthesia again.".

• Brand Name: FOOT RING LONG HOFFMANN LRF 180MM
• 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: 10693737
• Report Number: 0008031020-2020-02330
• Device Sequence Number: 2953380
• Product Code: KTT
• UDI-Device Identifier: 07613252611370
• UDI-Public: 07613252611370
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130907
• 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): 02/23/2021

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: 4934-4-180
• Device Catalogue Number: 49344180
• Device Lot Number: 17275Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 02/23/2021
• 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: 83 YR
• Patient Weight: 79