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

Model Number	4934-6-180
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/10/2020
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: "in reporting the fact that a hoffmann lrf foot arch came apart where the carbon fiber meets the metal on (b)(6) 2020, the surgeon reported the same problem happened with the same patient one week previously.".
Event or Problem Description
As reported, "in reporting the fact that a hoffmann lrf foot arch came apart where the carbon fiber meets the metal on (b)(6) 2020.The surgeon reported, the same problem happened with the same patient oneweek previously".
Additional Manufacturer Narrative
The reported event could be confirmed.The returned device was inspected by the manufacturing team, no abnormalities were noticed, during the manufacturing process.Therefore, the device broke when subjected to high forces.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.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by the application of large forces on the device.If any further information is provided, the complaint report will be updated.

• Brand Name: FOOT ARCH 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: 10953142
• Report Number: 0008031020-2020-02549
• Device Sequence Number: 2706022
• Product Code: KTT
• UDI-Device Identifier: 07613252611509
• UDI-Public: 07613252611509
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K130907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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: 4934-6-180
• Device Catalogue Number: 49346180
• Device Lot Number: 13650G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 03/19/2021
• 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