MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPS-ITE CRKSCRW 5.5X14.7MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMPS-ITE CRKSCRW 5.5X14.7MM
Date of Event	02/22/2022
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 not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2022 it was reported by a sales representative via sems that after normal insertion of tripleplay anchor and passing 3 limbs of suture there were no obvious problems with the ar-1927bcf-3 anchor.The surgeon then proceeded to tension the limbs in order to tie down the repair.While the surgeon began to pull both limbs of the blue suture the sales rep, noticed how it was pulling the tear up significantly.Both the surgeon and the sales rep noticed how the blue sutures weren¿t in the anchor anymore and had come free from the eyelet.The surgeon did not unload the anchor.It popped through the material eyelet.The sales rep asked him to lightly pull the solid whites and the same thing happened and once more with the stripes.The anchor remained fully seated in the bone but the eyelet was not holding any of the sutures not allowing us to use it for repair.This was discovered during use in a rotator cuff repair procedure.Additional information received 02/23/2022.On (b)(6) 2022 it was reported by a sales representative via email that after normal insertion of tripleplay anchor and passing 3 limbs of suture using the ar-1927bcf-3 anchor.The surgeon proceeded to tension the limbs to tie down the repair.While the surgeon began to pull both limbs of the blue suture the sales rep, noticed how it was pulling the tear up significantly.Both the surgeon and the sales rep noticed the blue sutures weren¿t in the anchor anymore and had come free from the eyelet.The surgeon did not unload the anchor.The surgeon lightly pulls the solid whites and the same thing happened and once more with the stripes.The anchor remained fully seated in the bone, but the eyelet was not holding any of the sutures not allowing us to use it for repair.This was discovered during use in a rotator cuff repair procedure. the case was completed by using the silver double lined punch ar-1927pb.The surgeon punched to the first laser line (ft) before anchor insertion.After the corkscrew sutures pulled out, we then used a fibertape and 4.75 swivelock to perform a speed fix.

• Brand Name: BIO-COMPS-ITE CRKSCRW 5.5X14.7MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, 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 ; 8009337001
• MDR Report Key: 13757294
• Report Number: 1220246-2022-04588
• Device Sequence Number: 11361570
• Product Code: MAI
• UDI-Device Identifier: 00888867023369
• UDI-Public: 00888867023369
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/14/2022

1 Device 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 Model Number: BIO-COMPS-ITE CRKSCRW 5.5X14.7MM
• Device Catalogue Number: AR-1927BCF-3
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 03/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial