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

Model Number	BICEPS BUTTON
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1220246-2022-05312
• Device Sequence Number: 15277798
• Product Code: MBI
• UDI-Device Identifier: 00888867026483
• UDI-Public: 00888867026483
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K123341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

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