MAUDE Adverse Event Report: ARTHREX, INC. CORKSCREW FT, BC, SUTURETAPE, 4.75MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	CORKSCREW FT, BC, SUTURETAPE, 4.75MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rectus tendon refixation on the right pelvis the corkscrew broke.All parts were retrieved from the patient.There was no harm for patient, operator or third party.The surgery was finished successfully with a device from another manufacturer.It was not necessary to switch the surgical technique or do a second surgery.
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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-1927bct-475-1 serial/batch number (b)(6) was received for evaluation.Visual inspection revealed that the 4.75 mm corkscrew was damaged.The implant was broken at the distal end damaging the screw geometry.It was noted that the suture was detached from the handle with no major damaged.The most likely cause for the reported failure can be attributed to improper misaligned insertion, prying, or leveraging the device during insertion.According to dfu-0087 at revision 3 g.Precautions.3.Make sure to use the recommended drill bit or punch to create the bone socket.4.Pushlock and swivelock suture anchors only: during anchor insertion, ensure that the angle of anchor insertion is coaxial to that of the previously prepared bone socket.5.Pushlock and swivelock suture anchors only: insert the driver into the bone socket until the anchor body makes contact with the bone.Preview and adjust suture tension, if necessary.Tension will not increase during final advancement of the anchor body.

• Brand Name: CORKSCREW FT, BC, SUTURETAPE, 4.75MM
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: jared engle ; 8009337001
• MDR Report Key: 19644364
• Report Number: 1220246-2024-06523
• Device Sequence Number: 15111353
• Product Code: MAI
• UDI-Device Identifier: 00888867237865
• UDI-Public: 00888867237865
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K173788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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 Model Number: CORKSCREW FT, BC, SUTURETAPE, 4.75MM
• Device Catalogue Number: AR-1927BCT-475-1
• Device Lot Number: 15143543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown