MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. 2MM OLIVE WIRE WITH DRILL LONG

Model Number 1405-2002

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

The olive wire is provided to customers within a sterile kit (sk12) and marked single use.The udi referenced is for the sterile kit, sk12, that the product is distributed within.The device history record was reviewed and no issues were identified during the manufacture and release of the device that could have contributed to the problem reported.The olive wire is manufactured with implant grade material.Evaluation of the returned device found that a portion of the fluted tip on the olive wire broke off right before the end of the fluting meets the shaft of the device.Based on the available information, photographic evidence and evaluation; it is possible the technique utilized on the olive wire applied additional forces resulting in its breakage.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 this 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.

Event Description

During a bunion procedure on (b)(6) 2018, the tip of a long olive wire broke off and was implanted in the patient's bone.The surgery preceded without further incident and was successfully completed.No case delay or additional patient outcomes were reported.

• Brand Name: 2MM OLIVE WIRE WITH DRILL LONG
• 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: jacklyn hayman ; 203 fort wade road, suite 150; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 8203969
• MDR Text Key: 132220882
• Report Number: 3011623994-2018-00055
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00853114006006
• UDI-Public: (01)00853114006006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A-CLASS I
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1405-2002
• Device Lot Number: OM18202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2018
• 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