MAUDE Adverse Event Report: ARTHREX, INC. CORKSCREW FT, BC, SUTURETAPE, 4.75M; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	CORKSCREW FT, BC, SUTURETAPE, 4.75M
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a rotator cuff surgery after drilling with the needle both used anchors broke off.No debris or fragments remained inside the patient and every fragment was retrieved out of the patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully.It was not necessary to switch the surgical technique or do a second surgery.12-jan-2022 update: further information were provided that the first broken anchor was retrieved out of the patient and a part of the second implant which broke remained inside the patient.
Additional Manufacturer Narrative
Complaint confirmed, fragments of the ar-1927bct-475-1 anchor were returned.No measurements could be verified due to the condition of the fragments.The cause of the event is undetermined, however likely causes include improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: CORKSCREW FT, BC, SUTURETAPE, 4.75M
• 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: 13394032
• Report Number: 1220246-2022-04344
• Device Sequence Number: 17299025
• Product Code: MAI
• UDI-Device Identifier: 00888867237865
• UDI-Public: 00888867237865
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: CORKSCREW FT, BC, SUTURETAPE, 4.75M
• Device Catalogue Number: AR-1927BCT-475-1
• Device Lot Number: 11956609
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown