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

Catalog Number AR-2269

Device Problems Component Missing (2306); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/16/2017

Event Type  Injury  

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 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
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, 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, sr mdr analyst ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 6656266
• MDR Text Key: 78034188
• Report Number: 1220246-2017-00218
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867026582
• UDI-Public: 00888867026582
• 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: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Catalogue Number: AR-2269
• Device Lot Number: 10059387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 118