MAUDE Adverse Event Report: ARTHREX, INC. HOLDING SLEEVE, 2.0MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	HOLDING SLEEVE, 2.0MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one of the four "claws" on the ar-18700-25 holding sleeve used to pull the screws broke off.See source data and image attached.The issue occurred during a metacarpal fracture procedure, but did not affect the surgery at all.All that broke was the screw holding sleeve which just made it a little less easy to grab screws.The rep reported this device does not go into or near the patient.The piece that broke got thrown away by the tech.No unplanned incisions and the case was completed as normal.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.It was reported that the prong broke.Visual evaluation of photos provided by the customer identified that the prong had fractured off the device.However, without the return of the holding sleeve, further investigation cannot be performed.The most likely cause for the reported failure can be attributed to user error due to user-applied mechanical forces via prying/leveraging.The reported event is confirmed based on the investigation of the returned picture.

• Brand Name: HOLDING SLEEVE, 2.0MM
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: jared engle ; 8009337001
• MDR Report Key: 19536238
• Report Number: 1220246-2024-05772
• Device Sequence Number: 6216593
• Product Code: LXH
• UDI-Device Identifier: 00888867312746
• UDI-Public: 00888867312746
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Report Date (Section B): 06/14/2024

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: HOLDING SLEEVE, 2.0MM
• Device Catalogue Number: AR-18700-25
• Device Lot Number: 1391947
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown