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

Model Number	SK26
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2020, the patient began having pain at the surgical site.During a follow-up visit on (b)(6) 2021, it was confirmed via radiographic imaging that a compression screw was backing out.Additional information received on (b)(6) 2021 indicates the screw was removed on (b)(6) 2021 and the patient reported an improvement.The device was not returned to the manufacturer for evaluation.The specific part and lot information of the reported screw was not provided.The udi referenced is for the sterile kit, (sk26), that the product is distributed within.The device history records for the screws within the sk26 kit were reviewed and no issues were identified during the manufacture and release of the devices that could have contributed to what was reported.There was no other report of any patient impact or injury as a result of this event.Based on the available information, the most likely root cause cannot be determined due the device not being returned for evaluation.However, it is possible the initial placement of the screw and/or post-operative activity of the patient led to loosening and an eventual backing out of the screw.The instructions for use identifies warnings related to postoperative care and the surgical technique instructs on the proper method for inserting compression screws.The company will supplement this mdr as necessary and appropriate.
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2020, the patient began having pain at the surgical site.During a follow-up visit on (b)(6) 2021, it was confirmed via radiographic imaging that a compression screw was backing out.Additional information received indicates the screw was removed on (b)(6) 2021 and the patient reported an improvement.There was no other report of any patient impact or injury as a result of this event.

• Brand Name: LAPIPLASTY 4.0MM HEADLESS SCREW
• Common Device Name: SCREW
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS, INC.; 203 fort wade road, suite 150; ponte vedra FL 32081
• MDR Report Key: 11942136
• Report Number: 3011623994-2021-00025
• Device Sequence Number: 4420537
• Product Code: HWC
• UDI-Device Identifier: 00853114006198
• UDI-Public: 00853114006198
• 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: 2020
• Device Explanted Year: 2021
• 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): 06/04/2021

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: 01/23/2023
• Device Model Number: SK26
• Device Lot Number: 34604
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 06/04/2021
• 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