MAUDE Adverse Event Report: ARTHREX, INC. DRILL, FOR FIBERTAK DR; DRILL BIT

Model Number DRILL, FOR FIBERTAK DR

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/27/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, it was reported by a sales rep.Via email that an ar-3657, drill, for fibertak¿ dr, drill tip broke in the patient when drilling with the 2.6 fibertak drill.This was detected during use in a subpectoralis biceps tenodesis procedure on (b)(6) 2023.The procedure was completed successfully by using another drill.(b)(6) 2023 - the sales rep mentioned that the broken piece was not retrieved as it was buried deep in the bone.There are also no further surgery planned that the sales rep is aware of.

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

• Brand Name: DRILL, FOR FIBERTAK DR
• Type of Device: DRILL BIT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 18394283
• MDR Text Key: 331331384
• Report Number: 1220246-2023-09617
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DRILL, FOR FIBERTAK DR
• Device Catalogue Number: AR-3657
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1