MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, BIO- COMPOSITE SUTURETAK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTURE ANCHOR, BIO- COMPOSITE SUTURETAK
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/10/2021
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 an arthroscopic procedure while inserting the anchor it broke.The surgeon was able to retrieve the parts out of the patient.There was no harm for patient, operator or third party reported.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.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1934bcf-1 was received for investigation.Visual inspection identified that the bio-composite anchor at the distal tip of the suturetak partially broke at the third proximal-most thread, with the remainder of the anchor noticeably bent out of position.The method used to prepare the bone employed during the procedure, as well as the bone quality encountered, were not provided.Probable causes are attributed to improper bone preparation and/or prying/leveraging the suturetak during the insertion process.

• Brand Name: SUTURE ANCHOR, BIO- COMPOSITE SUTURETAK
• 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: 12896587
• Report Number: 1220246-2021-04015
• Device Sequence Number: 5734742
• Product Code: MAI
• UDI-Device Identifier: 00888867097001
• UDI-Public: 00888867097001
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• 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: 03/31/2025
• Device Model Number: SUTURE ANCHOR, BIO- COMPOSITE SUTURETAK
• Device Catalogue Number: AR-1934BCF-1
• Device Lot Number: 13036568
• 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: 11/10/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown