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

Model Number	SK18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2019, all hardware was removed in a revision surgery due to what the patient believed was her "body rejecting it." no additional information has been received to date confirming the patient has a metal allergy.No devices were returned to the manufacturer for evaluation.The device history records for all devices intended to be implanted were reviewed (1405-1085 and 1405-1087) and no issues were identified during the manufacture and release of the devices that could have contributed to the problem reported.The other devices explanted in the same revision surgery were also tmc devices which were reported in mdrs 3011623994-2021-00054 and 3011623994-2021-00056.Based on the limited information available and unsuccessful attempts to obtain additional information, the most likely cause of what was reported cannot be determined as it is unknown if the patient underwent allergy testing to confirm metal as the source.No facts suggest a causal relationship between the implantation/explantation of tmc devices and the patient's reaction.The company will supplement the mdr as necessary and appropriate.
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2019, all hardware was removed in a revision surgery due to what the patient believed was her "body rejecting it." no additional information has been received to date confirming the patient has a metal allergy.No other patient outcomes were reported as a result of this event.

• 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: 12641819
• Report Number: 3011623994-2021-00055
• Device Sequence Number: 1416530
• Product Code: HWC
• UDI-Device Identifier: 00853114006068
• UDI-Public: 00853114006068
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2022
• Device Model Number: SK18
• Device Lot Number: 26604
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 10/15/2021
• 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