MAUDE Adverse Event Report: ARTHREX INC. SUTURE ANCHOR, BIO-COMP PUSHLOCK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	AR-2922BC
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/15/2017
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 part remains in the patient and cannot be 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.The complaint device was not returned and the customer's complaint cannot be verified.No abnormalities were observed on the fifteen new returned samples.The most likely cause(s) of this event include not inserting the implant co-axial to the bone tunnel or 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 causes of this event are being 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 by a sales rep that during a labral repair procedure, the 2.4 bio-composite pushlock was inserted and while malletting, the anchor broke.A second anchor was opened and again, the bio-composite pushlock broke on insertion.This happened three more times for a total of 5 devices all with the same lot number (lot: 10143236).All broken pieces were retrieved and the adequate fixation was finally obtained with the 5 anchors implanted.Follow up investigation: all pieces of the broken implants were retrieved with graspers and a shaver.The 5 partial implants (of the same lot number) remained in patient with adequate fixation.

• Brand Name: SUTURE ANCHOR, BIO-COMP PUSHLOCK
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6845921
• Report Number: 1220246-2017-00324
• Device Sequence Number: 1419791
• Product Code: MAI
• UDI-Device Identifier: 00888867197664
• UDI-Public: 00888867197664
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 09/08/2017

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: 05/01/2019
• Device Model Number: AR-2922BC
• Device Lot Number: 10143236
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 09/06/2017
• 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; Required Intervention