MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWVLK SP, 4.75X24.5MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-2324BCM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The device was requested for evaluation but was not returned, therefore 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.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 additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a right rotator cuff repair procedure, the surgeon was attempting to insert a 4.75mmx24.5mm bio-composite swivelock when the tip broke off into the patient's joint.The surgeon retrieved some of the fragments with a grasper however, he was not confident that all pieces were retrieved.No attempts were made to confirm whether or not there were still device fragments left in the patient.A new 4.75mmx24.5mm bio-composite swivelock (lot unknown) was opened and used to complete the case without further incident.Slight delay in case.Patient is a (b)(6) male.Additional information obtained 3/28/17: the titanium portion of the device has a cone that is connected to the titanium pin with two flat legs attached from the back side of the cone to the titanium pin.The cone broke free from the pin during implantation.When the cone was retrieved only one of the connecting legs was attached to the cone.The other was not attached to the cone or the titanium pin.It is unknown if the missing titanium leg is in the patient as it was not found or retrieved.

• Brand Name: BIO-COMP SWVLK SP, 4.75X24.5MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6490498
• Report Number: 1220246-2017-00131
• Device Sequence Number: 13642514
• Product Code: MAI
• UDI-Device Identifier: 10888867026862
• UDI-Public: 10888867026862
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/13/2017

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: 11/01/2018
• Device Catalogue Number: AR-2324BCM
• Device Lot Number: 10078077
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2017
• Initial Report FDA Received Date: 04/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1220246-4/04/17-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR