MAUDE Adverse Event Report: ARTHREX, INC. HIP ARTHRSCPY MSTR DISP KIT W/BLD; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	HIP ARTHRSCPY MSTR DISP KIT W/BLD
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that during a surgery a nitinol wire broke off.There was no harm for patient, operator or third party reported.No further information received.Update 30-oct-2020: further information were provided that the nitinol wire broke off inside the patient during a hip arthroscopy and it remained inside the patient.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.

• Brand Name: HIP ARTHRSCPY MSTR DISP KIT W/BLD
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10771363
• Report Number: 1220246-2020-02297
• Device Sequence Number: 4087083
• Product Code: GFA
• UDI-Device Identifier: 00888867039865
• UDI-Public: 00888867039865
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/02/2020

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: 12/31/2024
• Device Model Number: HIP ARTHRSCPY MSTR DISP KIT W/BLD
• Device Catalogue Number: AR-6526S
• Device Lot Number: 10571699
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 11/02/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other