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

Model Number	BIO-COMP SWVLK SP, 4.75X24.5MM
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the tip of the ar-2324bcm, suture anchor, bio-composite swivelock broke off as the surgeon was twisting the handle to insert the implant into the bone during an arthroscopy rotator cuff repair procedure.The rn stated that part of the implant remains securely in the patient.The facility confirmed that the device will be returning for evaluation.Additional information received on 10/15/2018: the facility confirmed that there was not a arthrex sales representative present during the procedure.The case was completed by using a 4.5 swivelock.The rn stated that a tap was used, and the bone quality was medium.
Additional Manufacturer Narrative
Additional information received on 01/02/2019: the device that was returned for evaluation (ar-2323bcm / lot: 10145068) did not match the part and lot number that was originally reported.The facility confirmed that the original part and lot number listed on the incident form was incorrect.The device that was returned (ar-2323bcm / lot: 10145068) is the device that broke during the procedure.The case was completed by using the ar-2324bcm (lot: f198317).The rn stated that they are not able to confirm if the ar-2324bcm used to complete the procedure was placed in the same hole, or if it was inserted in a different hole.Evaluation of the device shows: the complaint could not be confirmed, the driver returned appears intact and the broken components were not returned.

• 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: 8032198
• Report Number: 1220246-2018-00726
• Device Sequence Number: 1187732
• Product Code: MAI
• UDI-Device Identifier: 00888867026865
• UDI-Public: 00888867026865
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K151342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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: 02/29/2020
• Device Model Number: BIO-COMP SWVLK SP, 4.75X24.5MM
• Device Catalogue Number: AR-2324BCM
• Device Lot Number: F198317
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 01/03/2019
• 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: 71 YR
• Patient Weight: 221