MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, MICRO CORKSCREW FT; SCREW, FIXATION, BONE

Model Number	SUTURE ANCHOR, MICRO CORKSCREW FT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/07/2020
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 hand surgery the anchor cut the suture during screwing in.The broken off piece was retrieved from the patient.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.One unpackaged ar-1318ft-1 drive assembly (no batch indicator present) was received for investigation.Visual inspection identified that the micro corkscrew was not returned for analysis.However, the distal tip of the driver shaft was noticeably bent.Two of the curved needles and their associated suture constructs were returned, with breakage evident at the ends of both pieces of suture.The needles themselves remained intact.It was noted that the method of bone preparation employed during the procedure, as well as the bone quality encountered, were not recorded.The cause of the event remains undetermined, although the damage observed is most likely the result of user applied mechanical forces during use.

• Brand Name: SUTURE ANCHOR, MICRO CORKSCREW FT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11798580
• Report Number: 1220246-2021-03035
• Device Sequence Number: 1009801
• Product Code: HWC
• UDI-Device Identifier: 00888867282322
• UDI-Public: 00888867282322
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K112237
• 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): 08/11/2021

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: 08/31/2025
• Device Model Number: SUTURE ANCHOR, MICRO CORKSCREW FT
• Device Catalogue Number: AR-1318FT-1
• Device Lot Number: 11660756
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 08/11/2021
• Patient Sequence Number: 1