MAUDE Adverse Event Report: ARTHREX, INC. BICEPS BUTTON; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number BICEPS BUTTON

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Nerve Damage (1979)

Event Date 06/15/2022

Event Type  Injury  

Event Description

It was reported on 07/11/2022 by a facility representative via phone that an ar-7234 fiberloop, ar-2261 biceps button ar-2262 button inserter and ar-2263 drill were involved in a distal biceps repair, the patient suffered a continuing nerve issue after the surgery.Revision surgery (b)(6) 2022 to remove button and put in anchor.

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: BICEPS BUTTON
• Type of Device: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• 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: 15137725
• MDR Text Key: 296951336
• Report Number: 1220246-2022-05312
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867026483
• UDI-Public: 00888867026483
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123341
• 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: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BICEPS BUTTON
• Device Catalogue Number: AR-2261
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other