MAUDE Adverse Event Report: ARTHREX, INC. IMPL DELIVERY SYS,DISTAL BICEPS REPR; PLATE, FIXATION, BONE

Model Number IMPL DELIVERY SYS,DISTAL BICEPS REPR

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/22/2022

Event Type  malfunction  

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.

Event Description

On (b)(6) 2022, it was reported by a facility representative via medwatch email that a drill bit from an ar-2260 distal biceps repair implant system broke off in the patient's right shoulder.Surgeon did not retrieve the broken fragment due to causing more damage than leaving it in.This was discovered during a distal biceps repair on (b)(6) 2022.

• Brand Name: IMPL DELIVERY SYS,DISTAL BICEPS REPR
• Type of Device: PLATE, FIXATION, BONE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 14676460
• MDR Text Key: 302431186
• Report Number: 1220246-2022-05081
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867026476
• UDI-Public: 00888867026476
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMPL DELIVERY SYS,DISTAL BICEPS REPR
• Device Catalogue Number: AR-2260
• Device Lot Number: 14569982
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2022
• Date Device Manufactured: 11/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1