MAUDE Adverse Event Report: ARTHREX, INC. LARGE PEC BUTTON KIT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	AR-2269
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device disposition is unknown but has been requested.If available for evaluation return will be requested.The complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.The most likely cause(s) of this type of event is prying/leveraging the driver while the implant is still loaded.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If the additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported via medwatch (b)(4) that during a pectoralis major tendon repair the large pec button kit was used.After insertion of the pec major large eyelet into the humerus using a pec repair implant delivery system, it was noticed that one of the stylets used in the process was missing a threaded portion.The missing portion measured approximately 2 x 1 mm.The wound was explored and the fragment was not found.

• Brand Name: LARGE PEC BUTTON KIT
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6656266
• Report Number: 1220246-2017-00218
• Device Sequence Number: 19202016
• Product Code: MBI
• UDI-Device Identifier: 00888867026582
• UDI-Public: 00888867026582
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/21/2017

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 Expiration Date: 06/01/2021
• Device Catalogue Number: AR-2269
• Device Lot Number: 10059387
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 06/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Weight: 118