MAUDE Adverse Event Report: ARTHREX, INC. SLAPDRIVER, RATCHETING QUICK CONNECT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SLAPDRIVER, RATCHETING QUICK CONNECT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
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.The device was not received for evaluation; no photos of the failure were provided.Per the event description, the most likely cause of the reported failure is wear and damage caused by repeated use and/or reprocessing.The complaint's allegation cannot be confirmed without the evaluation of the device.
Event or Problem Description
On 5/19/2023, it was reported by a distributor via sems that an ar-1999sd ratcheting handle slap driver broke during a procedure.Nothing broke inside the patient.The handle became fixed, and the shaft broke.This was discovered during a procedure, date is unknown.

• Brand Name: SLAPDRIVER, RATCHETING QUICK CONNECT
• 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: 19505350
• Report Number: 1220246-2024-05491
• Device Sequence Number: 6913732
• Product Code: LXH
• UDI-Device Identifier: 00888867351301
• UDI-Public: 00888867351301
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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: SLAPDRIVER, RATCHETING QUICK CONNECT
• Device Catalogue Number: AR-1999SD
• Device Lot Number: 78422110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2021
• 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