MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PEEK CORKSCREW FT; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	SUTURE ANCHOR, PEEK CORKSCREW FT
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder arthroscopy the suture broke while it was tightened.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with a different part number.It was not necessary to switch the surgical technique or do a second surgery.18-nov-2021 update dw: further information was provided that the blockage of the suture fell out and broke inside.The suture broke and the anchor became detached during the procedure.
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
Complaint confirmed, even though the suture was not returned, the anchor was returned loose.The cause of the suture breaking is undetermined.No damage was observed on the driver.The tip of the anchor is damaged and the 1st thread stripped, the cause of which is undetermined.

• Brand Name: SUTURE ANCHOR, PEEK CORKSCREW FT
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, 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: 12895533
• Report Number: 1220246-2021-04006
• Device Sequence Number: 5942507
• Product Code: MBI
• UDI-Device Identifier: 00888867023635
• UDI-Public: 00888867023635
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K143745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: SUTURE ANCHOR, PEEK CORKSCREW FT
• Device Catalogue Number: AR-1927PSF-1
• Device Lot Number: 13196101
• 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: 11/08/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown