MAUDE Adverse Event Report: TRIMED, INC 5TH MET SCREW 4.5, 55MM

Model Number	JHEX4555
Medical Device Problem Codes	Fracture (1260); Unintended Collision (1429)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
A trimed sales rep located in the united states reported on (b)(6) 2020 that a acrew (jhex4555) had broken in the patient.The patient stated that while playing basketball he fell and broke his toe along with the screw that was implanted 2 years prior, x-ray images were taken to confirm that the toe and screw had both broken.The screw was originally implanted on (b)(6) 2018, and was removed on (b)(6) 2020.These screws are designed to stay in the patient forever.After, the removal of the screw a new plate and screws were placed on the bone to achieve fixation of the new break.The surgeon reported that this did not cause the patient any further harm.As of (b)(6) 2020, the patient is healing well.

• Brand Name: 5TH MET SCREW 4.5, 55MM
• Common Device Name: 5TH MET SCREW 4.5, 55MM
• Manufacturer (Section D): TRIMED, INC; 27533 avenue hopkins; santa clarita CA 91355
• MDR Report Key: 10550707
• Report Number: 2031009-2020-00003
• Device Sequence Number: 2409914
• Product Code: HRS
• UDI-Device Identifier: 00842188107184
• UDI-Public: 00842188107184
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K112794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 09/17/2020

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: JHEX4555
• Device Catalogue Number: JHEX4555
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2020
• 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