MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,BIO-COMP P-LCK,2.9X 12.5MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCH,BIO-COMP P-LCK,2.9X 12.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
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 surgery the anchor broke in two parts when inserting the device without applying pressure.The eyelet was not damaged.The two broken parts were retrieved from the patient.There was no harm for patient, operator or third party reported.No further information received.Update avoe 03-apr-2023 further information was provided that the error occurred during a labrum refixation surgery.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, khe, 26-apr-2023 further information was received with the device.Only the broken part was sent in, the ar-2923bc-1 was discarded.
Additional Manufacturer Narrative
The complaint is confirmed.One unpackaged ar-2923bc-1 was received for investigation.The only returned part was the eyelet and the 2.9mm pushlock.No functional test was performed on the received devices due to the damage.Visual evaluation found that the bio is damaged at the distal end of the screw missing the geometry.Also, a crack was observed.The method of bone preparation employed during the procedure and bone quality encountered was not provided.Per dfu-0087.Section g.Precautions.During the insertion, ensure that the angle of the anchor insertion is coaxial to the of the previously prepared bone socket¿the most likely cause for applying excessive force applied during use.Per event description: update avoe 03-apr-2023.¿further information was provided that the error occurred during a labrum refixation surgery¿.It is unknown details of the type of error that occurred during the procedure.The most likely cause for the reported failure is a user error.

• Brand Name: SUTR ANCH,BIO-COMP P-LCK,2.9X 12.5MM
• 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: 16838879
• Report Number: 1220246-2023-06632
• Device Sequence Number: 7527750
• Product Code: MAI
• UDI-Device Identifier: 00888867269170
• UDI-Public: 00888867269170
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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: 12/31/2024
• Device Model Number: SUTR ANCH,BIO-COMP P-LCK,2.9X 12.5MM
• Device Catalogue Number: AR-2923BC-1
• Device Lot Number: 15044923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• 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