MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,BIO-COMP S-TAK SM JNT; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCH,BIO-COMP S-TAK SM JNT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2021
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 ankle fracture/ligament repair surgery the surgeon drilled the bone using the bone drill from the drill kit.Upon insertion, the device broke off and crumbled.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.
Additional Manufacturer Narrative
Complaint confirmed, the anchor was returned broke at its base but still connected to the suture.The proximal end fragment remains assembled with the driver.No other abnormalities were observed.The cause of the event is undetermined, however a likely cause is prying/leveraging the device during insertion.

• Brand Name: SUTR ANCH,BIO-COMP S-TAK SM JNT
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12361332
• Report Number: 1220246-2021-03542
• Device Sequence Number: 14264276
• Product Code: MAI
• UDI-Device Identifier: 00888867050365
• UDI-Public: 00888867050365
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

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: 02/28/2025
• Device Model Number: SUTR ANCH,BIO-COMP S-TAK SM JNT
• Device Catalogue Number: AR-8934BCNF
• Device Lot Number: 12900183
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 10/25/2021
• Patient Sequence Number: 1