MAUDE Adverse Event Report: ARTHREX, INC. 4.5X14MM BC CORKSCREW FT, DX; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	4.5X14MM BC CORKSCREW FT, DX
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
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 two ar-8927bc from lot: 11616289 broke in the same spot while implanting in the patient.The second one had a portion stuck inside patient so the surgeon used the needles to do the repair.
Additional Manufacturer Narrative
It was reported that two anchors broke during implantation.The reported event is confirmed upon investigation of the returned pictures.Visual evaluation identified that both anchors had fractured upon insertion.However, without the return of the product, further evaluation cannot be performed.The root cause of the reported failure mode is undetermined.However, the most likely probable causes are applying excessive mechanical forces upon insertion and inadequate bone preparation.

• Brand Name: 4.5X14MM BC CORKSCREW FT, DX
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11314704
• Report Number: 1220246-2021-02583
• Device Sequence Number: 4116744
• Product Code: MAI
• UDI-Device Identifier: 00888867131521
• UDI-Public: 00888867131521
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4.5X14MM BC CORKSCREW FT, DX
• Device Catalogue Number: AR-8927BC
• Device Lot Number: 11616289
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 09/03/2021
• 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