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

Model Number TPEG-20

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problems Pain (1994); Implant Pain (4561)

Event Date 09/05/2023

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 323250280
• Report Number: 2031009-2023-00006
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00842188108389
• UDI-Public: 00842188108389
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TPEG-20
• Device Catalogue Number: TPEG-20
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention