MAUDE Adverse Event Report: TRIMED INC 1ST MTP 0 DEGREE DORSIFLEXED,LT,9-HOLE

Model Number	MTPL-9
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A trimed sales representative reported on (b)(6) 2022 that a mtpl-9 had broken in the patient.It was stated that the surgeon had a (b)(6) patient who had a previously failed toe implant (not a trimed product), the surgeon removed the silastic implant and put an allograft bone wedge in and plated with the mtpl-9.It was stated by the sales rep and surgeon that the fracture looked fused and was doing well when there was a sudden onset of pain 3 months post surgery (initial surgery date unknown), it was also mentioned that the patient typically has surgery complications.Lastly, it was stated that the surgeon plans to remove the hardware, the surgery date is currently unknown.The surgeon does not believe that this issue will cause any lasting issues in the patient.
Additional Manufacturer Narrative
It was stated on (b)(6) 2022 that the surgeon does not believe the plate itself caused or contributed to the serious injury.
Event or Problem Description
A trimed sales representative reported on 26 apr 2022 that the surgeon does not believe the plate itself caused or contributed to the serious injury.

• Brand Name: 1ST MTP 0 DEGREE DORSIFLEXED,LT,9-HOLE
• Common Device Name: 1ST MTP 0 DEGREE DORSIFLEXED,LT,9-HOLE
• Manufacturer (Section D): TRIMED INC; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer (Section G): TRIMED INC; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer Contact: stephanie miranda ; 27533 avenue hopkins; santa clarita, CA 91355
• MDR Report Key: 14084240
• Report Number: 2031009-2022-00002
• Device Sequence Number: 11293098
• Product Code: HRS
• UDI-Device Identifier: 00842188119989
• UDI-Public: 00842188119989
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K192696
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

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: Health Professional
• Device Model Number: MTPL-9
• Device Catalogue Number: MTPL-9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female