MAUDE Adverse Event Report: ARTHREX, INC. PEEK, 3.9MM KNOTLESS CORKSCREW W/ #5 MTS; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	PEEK, 3.9MM KNOTLESS CORKSCREW W/ #5 MTS
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/30/2020
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 a surgeon was doing a remplissage using 3.9 knotless corkscrews (ar-1941psv, lot 10747047).Surgeon used a disposable kit (ar-1941ds, lot 11238107), with guide and punch and followed proper technique for insertion.As surgeon began twisting the anchor in, she heard a sound and then saw the anchor was cracked.The anchor was almost fully inserted but sitting a bit proud.Surgeon tried to remove the cracked anchor body but had a hard time so she ended up removing and cutting out the sutures and the anchor body remained in the patient but did not cause harm.The case was completed by using 2 new anchors with the same lot number.

• Brand Name: PEEK, 3.9MM KNOTLESS CORKSCREW W/ #5 MTS
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11192523
• Report Number: 1220246-2021-02485
• Device Sequence Number: 16335362
• Product Code: MBI
• UDI-Device Identifier: 00888867344921
• UDI-Public: 00888867344921
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K193157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/19/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: PEEK, 3.9MM KNOTLESS CORKSCREW W/ #5 MTS
• Device Catalogue Number: AR-1941PSV
• Device Lot Number: 10747047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 01/19/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other