MAUDE Adverse Event Report: TRIMED 1ST MTP 0 DEGREE DORSIFLEXED,RT,7-HOLE

Model Number	MTPR-7
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	02/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) reported on (b)(6) 2023 that a surgeon removed a mtpr-7 plate from a patient due to a break at the joint line because the mpj did not fuse.All hardware was successfully removed from the patient and an arthroplasty revision was performed after removal.The removal surgery did not have any delays.The hardware is available for return but no pictures or x-rays have been provided.

• Brand Name: 1ST MTP 0 DEGREE DORSIFLEXED,RT,7-HOLE
• Common Device Name: 1ST MTP 0 DEGREE DORSIFLEXED,RT,7-HOLE
• Manufacturer (Section D): TRIMED; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer (Section G): TRIMED; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer Contact: megan rissler ; 27533 avenue hopkins; santa clarita, CA 91355
• MDR Report Key: 16518527
• Report Number: 2031009-2023-00002
• Device Sequence Number: 19671506
• Product Code: HRS
• UDI-Device Identifier: 00842188120015
• UDI-Public: 00842188120015
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K192696
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2023

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: MTPR-7
• Device Catalogue Number: MTPR-7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male