MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. 2MMX40MM SUB-OLIVE WIRE WITH THREADED TIP

Model Number 1405-2015

Device Problems Break (1069); Patient-Device Incompatibility (2682)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/11/2021

Event Type  malfunction  

Event Description

It was reported that the tip of a threaded olive wire broke off and was retained in the patient's bone during a bunion procedure on (b)(6) 2021.A backup device was available to successfully complete the case with no additional patient outcomes.

Manufacturer Narrative

It was reported that the tip of a threaded olive wire broke off and was retained in the patient's bone during a bunion procedure on (b)(6) 2021.Additional information indicates the olive may have broken due to the patient having "strong bone." the device was not returned for evaluation, but photographic evidence was reviewed and confirmed that the olive wire broke off right before the threading meets the shaft of the device.The udi referenced is for the sterile kit, sk14, the product is distributed within.The device history records for all possible lots were reviewed and no issues were identified during the manufacture and release of the devices that could have contributed to what was reported.Based on the available information, the cause of what was reported is likely due to the patient having hard cortical bone.A backup device was available to successfully complete the case with no additional patient outcomes.Although the company has determined that the subject event in this mdr is unlikely to result in a serious injury if it recurred, the company has decided to file the mdr in an abundance of caution and to ensure full compliance with 21 cfr part 803.The company will supplement this mdr as necessary and appropriate.

• Brand Name: 2MMX40MM SUB-OLIVE WIRE WITH THREADED TIP
• Type of Device: OLIVE WIRE
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS, INC.; 203 fort wade road, suite 150; ponte vedra FL 32081
• Manufacturer (Section G): TREACE MEDICAL CONCEPTS, INC.; 203 fort wade road, suite 150; ponte vedra FL 32081
• Manufacturer Contact: julia white ; 203 fort wade road, suite 150; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 12970641
• MDR Text Key: 285242036
• Report Number: 3011623994-2021-00069
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00853114006051
• UDI-Public: 00853114006051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1405-2015
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2021
• 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 Age: 68 YR
• Patient Sex: Male