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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)2023, it was reported by a sales representative via sems that an ar-9510-2 broach handle broke off the threaded portion of the version rod into the 20° hole.This occurred during a case, another device was used.There was no effect on the patient.
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
The complaint allegation was confirmed.One unpackaged ar-9510-2 serial number, (b)(6), was received for investigation.Functional test with ar-9510-14 found that the device is functioning as intended.When the broach handled trigger was pressed, the matting part was released.The returned device was visually inspected, and it was noted that the 20° r hole is obstructed with a piece of presumably matting part ar-9510-01 that was broken off inside the hole.The visual inspection also noted severe signs of wear on the device, as many scratches, discoloration, and dents throughout the device¿s body.The most likely cause for the reported failure is user error for applying excessive force during use.

• 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: 17408405
• Report Number: 1220246-2023-07331
• Device Sequence Number: 7121866
• Product Code: LXH
• UDI-Device Identifier: 00888867290464
• UDI-Public: 00888867290464
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 11/04/2024

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 11/04/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown