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
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/18/2020
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.
Event or Problem Description
It was reported that during a (b)(6) 2020 rotator cuff repair procedure an ar-1927bcf-3 was being inserted and the suture had issue and the anchor body broke.The correct punch (ar-1927pb) was used and then tap (ar-1927ctb) was used.The sales representative states the suture had an issue before the anchor broke.A second anchor was then inserted and after two turns that anchor broke as well.The bone was not abnormally hard according to the surgeon.Since the first two anchors out of the box had issue the entire box was taken out of circulation.To complete the procedure the surgeon switched from an anchor repair to a suture only repair which was reported to have not been ideal for the surgeon.Portion of 1 anchor remained in the patient.The surgeon did not want to dig it out of the bone.What is left of the two opened anchors will be returned.In addition, 3 unused anchors from the open box will also be returned.
Additional Manufacturer Narrative
The reported event is confirmed for one out of the two corkscrews upon investigation of the returned product.Visual evaluation confirmed that one out of the two implants had broken.The distal part of the implant had broken in the threaded region and appeared to also contain dried blood.The implant for the second corkscrew was not returned and, therefore, the event cannot be confirmed for the second corkscrew.No damage or malfunction was found on both corkscrew shafts or handles.Additionally, the three packaged corkscrews were confirmed to be unopened and still intact.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces upon insertion.

• 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
• MDR Report Key: 10634245
• Report Number: 1220246-2020-02219
• Device Sequence Number: 2727959
• Product Code: MAI
• UDI-Device Identifier: 00888867023369
• UDI-Public: 00888867023369
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020

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: 07/31/2021
• Device Model Number: BIO-COMPS-ITE CRKSCRW 5.5X14.7MM
• Device Catalogue Number: AR-1927BCF-3
• Device Lot Number: 10349980
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 10/12/2020
• 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