MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, BIO-CORKSCREW FT; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTURE ANCHOR, BIO-CORKSCREW FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint is confirmed.One unpackaged ar-1927bcf serial/batch number (b)(6) was received for investigation.After visual evaluation, it was noted that the bio/implant screw arrived damaged/broken, missing half of the implant.No damage was observed on the shaft or handle.The most likely cause for the reported failure is user error.Per dfu-0087-eo revision 2.Warnings.6.Bioabsorbable only: attempting implantation into hard, dense bone and/or drilling/punching smaller diameter holes than recommended may cause failure (breakage) of the implant during insertion.
Event or Problem Description
It was reported that during a shoulder arthroscopy the function of the device didn`t release after three turns.There was no harm for patient, operator or third party reported.No further information received.Update avoe 15-mar-2023: further information was provided that no part of the device broke off.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update avoe 30-aug-2023: it was confirmed that the surgeon turned the device twice and on the third turn came the crack and the break.Everything was removed from the patient and the surgery was finished successfully with a new device with the same part number.

• Brand Name: SUTURE ANCHOR, BIO-CORKSCREW FT
• 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: emily shafer ; 8009337001
• MDR Report Key: 17671162
• Report Number: 1220246-2023-07762
• Device Sequence Number: 7124131
• Product Code: MAI
• UDI-Device Identifier: 00888867023352
• UDI-Public: 00888867023352
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061863
• 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
• Report Date (Section B): 09/01/2023

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: 02/29/2024
• Device Model Number: SUTURE ANCHOR, BIO-CORKSCREW FT
• Device Catalogue Number: AR-1927BCF
• Device Lot Number: 10763039
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2020
• 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