MAUDE Adverse Event Report: ARTHREX, INC. IMPL DELIVERY SYS,DISTAL BICEPS, BC; BIO SOFT TISSUE FIXATN FASTNR

Model Number IMPL DELIVERY SYS,DISTAL BICEPS, BC

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2023

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 11/2/2023, it was reported by a sales representative via phone that an ar-2260bc implant delivery system, biocomposite distal biceps repair, had a screw that did not fit in the inserter.The case was completed by swapping for another ar-2260bc from a different lot with no delay in the procedure.No fragment broke inside the patient.This was discovered during a distal biceps repair on 11/2/2023, with no reported patient harm.

• Brand Name: IMPL DELIVERY SYS,DISTAL BICEPS, BC
• Type of Device: BIO SOFT TISSUE FIXATN FASTNR
• 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: 18257763
• MDR Text Key: 329620015
• Report Number: 1220246-2023-09124
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867204645
• UDI-Public: 00888867204645
• 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: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• 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, BC
• Device Catalogue Number: AR-2260BC
• Device Lot Number: 15124403
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/04/2023
• 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