MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO MTP PLT,CONTRD,LNG,L,TI, STRL; PLATE, FIXATION, BONE

Model Number	AR-8944CL-LS
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that 6 months ago an arthrodese was performed with the mtp plate and innotere cylinder with an overweight patient.Now it was reported that the plate is broken and a revision surgery was done.Update 14-oct-2020 further information obtained: the initial surgery took place on (b)(6) 2020.The revision surgery was successfully performed on (b)(6) 2020.Update 15-oct-2020: revision surgery was finished successfully with spongiosa was removed from the iliac crest, inserted into the foot and fixed with screws.
Additional Manufacturer Narrative
It was reported that the plate had broken and the patient needed revision surgery.The reported event is confirmed upon investigation of the returned product.Visual evaluation identified that the plate had fractured, and unrelated to the reported event, displayed signs of use and discoloration.The root cause of the reported failure mode is undetermined.However, the most likely probable causes are applying excessive mechanical forces during post-op healing and wear and tear on the plate while implanted.

• Brand Name: LO-PRO MTP PLT,CONTRD,LNG,L,TI, STRL
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10746321
• Report Number: 1220246-2020-02260
• Device Sequence Number: 14246576
• Product Code: HRS
• UDI-Device Identifier: 00888867052895
• UDI-Public: 00888867052895
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: AR-8944CL-LS
• Device Catalogue Number: AR-8944CL-LS
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 01/04/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other