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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/12/2024, it was reported by a sales representative via (b)(6) that during a revers total shoulder procedure on (b)(6) 2024, two broach handles, ar-9510-2, were coming off the broach when trying to mallet out of the humeral canal.In addition, the baseplate inserter, ar-9623, would not come off the baseplate.The blue wheel on the handle was spinning but would not back off the baseplate.Additional information requested.
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: 052016-rw was received for investigation.Visual evaluation noted that the device had wear and tear with slight scratches throughout the device.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 to replicate the conditions in which the reported failure occurred.Functional testing revealed that when the ar-9510-2 lever-locking broach handle was struck repeatedly with the ar-2966 kirk mallet, the device would unlock and detach 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.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: jared engle ; 8009337001
• MDR Report Key: 18806705
• Report Number: 1220246-2024-01203
• Device Sequence Number: 15289214
• Product Code: LXH
• UDI-Device Identifier: 00888867290464
• UDI-Public: 00888867290464
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/23/2024

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?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 07/23/2024
• 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