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

Model Number	SUTURE ANCHOR, MICRO CORKSCREW FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/17/2023
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 third phalanx middle joint plastics of the ligaments an issue with the reported device occurred.After the anchor was fully inserted the inserter was taken off the anchor but the sutures going through the inserter stuck together with the little part of the end of the inserter.While the surgeon has handling the issue the metal part off the inserter broke off.Due to this failure the needles were cut of as the could not be used anymore.The surgeon was not able to release the sutures from the metal part and therefore retrieved the sutures including the broken metal piece but the anchor remained in the patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully with additional needles but it was also reported that the anchor was inserted but with insufficient result.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional info: h6 the complaint is confirmed.One unpackaged ar-1318ft-40-1 serial/batch number (b)(6) was received for investigation.Visual evaluation revealed that the driver¿s tip was broken off.It was noted that the shaft was slightly bent.The most likely cause for the reported failure is a user error.

• Brand Name: SUTURE ANCHOR, MICRO CORKSCREW FT
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 16929428
• Report Number: 1220246-2023-06737
• Device Sequence Number: 17875312
• Product Code: HWC
• UDI-Device Identifier: 00888867287068
• UDI-Public: 00888867287068
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: K112237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2023

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: 06/30/2026
• Device Model Number: SUTURE ANCHOR, MICRO CORKSCREW FT
• Device Catalogue Number: AR-1318FT-40-1
• Device Lot Number: 13821494
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2021
• 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