MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. 3MM COMPRESSION SCREW SYSTEM - INTERFRAG

Model Number	SK18
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	05/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery, all hardware was removed in a revision surgery on (b)(6) 2021 due to loose hardware and a painful non-union.The devices were not returned to the manufacturer for evaluation.The device history records for the sk18 were reviewed and no issues were identified during the manufacture and release of the devices that could have contributed to what was reported.Feedback from the surgeon indicates the patient "walked too soon" immediately following the initial surgery resulting in a plantar gap at the tmt joint and bent plates which were discovered upon removal.Based on the available information, the patients post-operative activity likely led to loosening/bending of the hardware and the resulting non-union.The device is intended for fusion and non-union is a known potential adverse event identified in the instructions for use provided with the sterile kit, along with warnings related to postoperative care.The surgeon addressed the site by revising it with new tmc devices.The company will supplement this mdr as necessary and appropriate.
Event or Problem Description
It was reported that after an initial bunion surgery, all hardware was removed in a revision surgery on (b)(6) 2021 due to loose hardware and a painful non-union.The surgeon believes the patient "walked too soon" resulting in a plantar gap at the tmt joint.Upon removal the plates were also discovered to be bent and the site was revised with new tmc hardware.

• Brand Name: 3MM COMPRESSION SCREW SYSTEM - INTERFRAG
• Common Device Name: SCREW
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS, INC.; 203 fort wade road, suite 150; ponte vedra FL 32081
• MDR Report Key: 12063365
• Report Number: 3011623994-2021-00030
• Device Sequence Number: 14289939
• Product Code: HWC
• UDI-Device Identifier: 00853114006068
• UDI-Public: 00853114006068
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

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 Expiration Date: 03/03/2023
• Device Model Number: SK18
• Device Lot Number: 34871
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 06/24/2021
• 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
• Patient Age: 52 YR