MAUDE Adverse Event Report: ARTHREX, INC. REVERS LEVER-LOCKING BROACH HANDLE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	REVERS LEVER-LOCKING BROACH HANDLE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via (b)(4) that an ar-9510-2 revers lever-locking broach handle is not functioning well.When it clicks in the broach, it doesn¿t always hold the broach in place.This was discovered during a procedure.The case was completed with another device with no patient harm.
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
Complaint allegation is confirmed.One unpackaged ar-9510-2 lever-locking broach handle batch number: 170802-rw was received for investigation.Visual evaluation noted that the device had wear- the device was discolored and had scratches.Further observation noted that the broach handle locking handle would not lock securely.Functional testing was performed by attaching an ar-9510-14 rasp/trial stem batch number: 250120700r to the lever-locking broach handle and hitting the device with an ar-2966 kirk mallet batch number: 6671619.As soon as the device was struck, it unlocked and detached from the ar-9510-14 rasp/trial stem.The most likely cause for these failures can be attributed to wear and tear incurred from repeated usage - date of manufacture 2022.Refer to investigation photos.

• Brand Name: REVERS LEVER-LOCKING BROACH HANDLE
• 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: emily shafer ; 8009337001
• MDR Report Key: 18483992
• Report Number: 1220246-2024-00236
• Device Sequence Number: 16825103
• Product Code: LXH
• UDI-Device Identifier: 00888867290464
• UDI-Public: 00888867290464
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 08/27/2024

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: REVERS LEVER-LOCKING BROACH HANDLE
• Device Catalogue Number: AR-9510-2
• Device Lot Number: 170802
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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