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

Model Number	LARGE PEC BUTTON
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Sales rep advised that, "on wednesday october 27th at 5pm i received an email from arthrex customer service.She had received a call from (b)(6) hospital.He explained that a patient had presented with infection issues arising from a previous sub pectoral biceps tenodesis using a large pec button from arthrex.He did not state when the surgery occurred.He was calling to ask what the material is of the large pec button and suture material.I stated the material make up (titanium and ultra high molecular polyethylene suture).
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: LARGE PEC 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: 12814506
• Report Number: 1220246-2021-03923
• Device Sequence Number: 4957476
• Product Code: MBI
• UDI-Device Identifier: 00888867026544
• UDI-Public: 00888867026544
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/15/2021

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: LARGE PEC BUTTON
• Device Catalogue Number: AR-2267
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/15/2021
• 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