MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC LAPIPLASTY 4.0MM HEADLESS SCREWS

Model Number	SK26
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2023, all hardware was removed on (b)(6) 2023 due to 2 broken screws that were discovered via radiographic imaging.Additional information indicates the patient had pain in the arch of the foot, nerve pain along the incision site, and a nonunion.The site was revised with non-tmc hardware.However, the tips of the broken screws were retained in the patient's bone as they could not be removed by the surgeon.No other patient outcomes were reported as a result of this event.No devices were returned for evaluation as the hardware was discarded by the facility.The device history records were reviewed and no issues were identified during the manufacture and release of the devices that could have contributed to what was reported.The most likely cause of the reported event could not be determined as the device was not returned for evaluation.However, it is possible premature weight bearing could have contributed to what was reported.The company will supplement this mdr as necessary and appropriate.Additional tmc hardware explanted in the same revision surgery was reported in mfr report # 3011623994_2023_00339.
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2023, all hardware was removed on (b)(6) 2023 due to 2 broken screws that were discovered via radiographic imaging.Additional information indicates the patient had pain in the arch of the foot, nerve pain along the incision site, and a nonunion.The site was revised with non-tmc hardware.However, the tips of the broken screws were retained in the patient's bone as they could not be removed by the surgeon.No other patient outcomes were reported.

• Brand Name: LAPIPLASTY 4.0MM HEADLESS SCREWS
• Common Device Name: SCREW
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS, INC; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer (Section G): TREACE MEDICAL CONCEPTS, INC; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer Contact: renae ginter ; 100 palmetto park place; ponte vedra, FL ; 9043735940
• MDR Report Key: 18416182
• Report Number: 3011623994-2023-00340
• Device Sequence Number: 15174488
• Product Code: HWC
• UDI-Device Identifier: 00853114006198
• UDI-Public: 00853114006198
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2023

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: SK26
• Device Lot Number: 40765
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• 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: 58 YR
• Patient Sex: Female