MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS SLAP HAMMER; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNIVERS SLAP HAMMER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/01/2025, a sales representative reported via (b)(4) that an ar-9202-14 univers¿ 3d slaphammers tip broke off.This occurred during a case with no patient affected.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One ar-9202-14 received for investigation.Visual evaluation confirms that the knob broke off from the head.Additionally, the device and markings markings are discolored.Functional testing was not performed due to the damage to the device.The most likely cause of the reported failure is wear and tear.Due to continuous mechanical forces applied to it, the device will inevitably sustain damage over time.The device was manufactured in 2018.Refer to the investigation photos the complaint allegation is confirmed.

• Brand Name: UNIVERS SLAP HAMMER
• 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: 21857605
• Report Number: 1220246-2025-01531
• Device Sequence Number: 7917263
• Product Code: LXH
• UDI-Device Identifier: 00888867058385
• UDI-Public: (01)00888867058385(11)180514(10)250170705
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 07/14/2025

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: UNIVERS SLAP HAMMER
• Device Catalogue Number: AR-9202-14
• Device Lot Number: 250170705
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2018
• 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