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

Model Number 4934-6-180

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event 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 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".

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
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10953142
• MDR Text Key: 219870087
• Report Number: 0008031020-2020-02549
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07613252611509
• UDI-Public: 07613252611509
• Combination Product (y/n): N
• PMA/PMN Number: K130907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention