MAUDE Adverse Event Report: ARTHREX, INC. HIP ARTHRSCPY DISP. KIT W/BANANA BLADE; MANUAL INSTR, GENERAL SURGICAL

Model Number	HIP ARTHRSCPY DISP. KIT W/BANANA BLADE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/28/2023
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 6/29/2023, it was reported by a sales representative via sems that the banana blade from an ar-6527s hip arthroscope disposable kit broke inside the patient.This was not discovered until the patient went for a post-operative visit.An x-ray scan confirmed there was a foreign object inside the patient.On (b)(6) 2023, the patient underwent revision surgery to remove the broken fragments.The revision procedure was conducted smoothly with no complications, and the fragments were fully retrieved.Additional information requested.
Event or Problem Description
Additional information received on 7/5/2023: the original procedure date is unknown at this time.Both surgeries were performed at the same facility and by the same surgeon.The lot number used is also unknown.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-6527s was received for evaluation the batch could not be identified because the received piece is too small.The visual inspection indicated that the received metal piece has a bend and a cut, likely due to contact with another instrument.The most likely cause is the application of excessive mechanical force during insertion or use.

• Brand Name: HIP ARTHRSCPY DISP. KIT W/BANANA BLADE
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: emily shafer ; 8009337001
• MDR Report Key: 17378699
• Report Number: 1220246-2023-07270
• Device Sequence Number: 12314812
• Product Code: MDM
• UDI-Device Identifier: 00888867039902
• UDI-Public: 00888867039902
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: HIP ARTHRSCPY DISP. KIT W/BANANA BLADE
• Device Catalogue Number: AR-6527S
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown