MAUDE Adverse Event Report: TRIMED TORX THREADED PEG, 20MM

Model Number	TPEG-20
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Health Effect - Clinical Codes	Pain (1994); Implant Pain (4561)
Date of Event	09/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Sales rep reported on 11jul2023 that when a surgeon was inserting the last tpeg-20 into a vlbpr-3-7 the head of the screw broke off.The screw was being placed into a bearing hole and it was not inserted under power.It was reported that the screw is still in the patient and locked into the plate.This did cause a slight delay in surgery.The broken screw head was removed from the patient and the surgeon does not believe that the head breaking off will cause the patient any additional harm.The head of the screw was discarded, one picture was provided, however x-rays are not available.Additional information was received on 10sep2023 that a revision surgery was done on (b)(6) 2023 to remove the plate and screw construct due to patient discomfort.It was reported that the rep is unsure if the patient was weight bearing too early.

• Brand Name: TORX THREADED PEG, 20MM
• Common Device Name: TORX THREADED PEG, 20MM
• 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: 17733481
• Report Number: 2031009-2023-00006
• Device Sequence Number: 17611169
• Product Code: HRS
• UDI-Device Identifier: 00842188108389
• UDI-Public: 00842188108389
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K040112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 09/12/2023

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: TPEG-20
• Device Catalogue Number: TPEG-20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2023
• 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: Required Intervention
• Patient Sex: Unknown