MAUDE Adverse Event Report: ARTHREX, INC. DX SWIVELOCK, 3.5 X 13.5 MM; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	DX SWIVELOCK, 3.5 X 13.5 MM
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a foot arthroscopy the implant broke.The device broke before the insertion in the patient.There was no harm for patient, operator or third party.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.Update (b)(6) 2023: further information revealed that the device broke inside the patient.The device was not removed but did not obstruct further steps in the operation.
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
The complaint is not confirmed.One unpackaged ar-8979p-1 serial/batch number 14978548 was received for investigation.The received device for investigation arrived without the broken implant and the sutures.Functional test of the driver outer sleeve and the tb inner member molded swivelock found that the devices thread smoothly.Visual evaluation did not find issues with the returned parts.Visual evaluation of the attached picture; it was noted that the device was disassembled.The complaint cannot be confirmed because there is no picture of the broken implant, and the returned device was received incomplete.

• Brand Name: DX SWIVELOCK, 3.5 X 13.5 MM
• 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: 16263502
• Report Number: 1220246-2023-06183
• Device Sequence Number: 15300943
• Product Code: MBI
• UDI-Device Identifier: 00888867287709
• UDI-Public: 00888867287709
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K150648
• 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): 08/14/2023

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 Model Number: DX SWIVELOCK, 3.5 X 13.5 MM
• Device Catalogue Number: AR-8979P-1
• Device Lot Number: 14978548
• 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: 01/12/2023
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown