MAUDE Adverse Event Report: ARTHREX, INC. 3.9MM KNOTLESS CORKSCREW, PEEK; SCREW, FIXATION, BONE

Model Number	3.9MM KNOTLESS CORKSCREW, PEEK
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/27/2020
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 the ar-1941ps, 3.9 corkscrew anchor (s704108), was unable to be fully implanted.The screw driver stripped the anchor causing it to not be able to be advanced to a seated position and was not able to be removed.The anchor needed to be burred down and another anchor was put in it's place.Initial report also stated that no part of the implant was left in the patient.Surgeon has experience using the device.There is no device to return.Additional information has been requested.Additional information provided 6/1/2020: the procedure was a rwmplissage.A 3.9 punch was used to prepare the bone.The bone quality was average and acceptable for use of a punch vs.A drill.The anchor was partially removed.The bottom half was left in the patient and not able to be removed.The top half of the anchor was burred off.The sales rep has confirmed that the new anchor was a 3.9 suturetak which was placed next to the original 3.9 corkscrew anchor.

• Brand Name: 3.9MM KNOTLESS CORKSCREW, PEEK
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10159959
• Report Number: 1220246-2020-01901
• Device Sequence Number: 11559375
• Product Code: HWC
• UDI-Device Identifier: 00888867270794
• UDI-Public: 00888867270794
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 3.9MM KNOTLESS CORKSCREW, PEEK
• Device Catalogue Number: AR-1941PS
• Device Lot Number: S704108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 06/16/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other