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

Model Number	SLAP HAMMER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
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-613-99 slap hammer broke.This was discovered during a procedure.Additional information received on 8/29/2023: this was discovered during a tka procedure on (b)(6) 2023.The slap hammer broke when taking off the cruciate prep guide, but it did not break off inside the patient.The case was completed using another ar-613-99 slap hammer.The case was delayed for about ten minutes because the instrument had to be sterilized.The patient received additional anesthesia for the extra case time.No patient harm or significant symptoms have been reported.
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
Additional information: d9, g3, h3, h6.Complaint is confirmed.Visual evaluation noted that the handle cap, t-slot boss and ball-nose spring plunger at distal end of the shaft was broken off of the assembly slap hammer.Functional testing was not performed due to the damage to the device.The most likely cause of this condition is the excessive force used to pry and/or leverage the device.

• Brand Name: 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: emily shafer ; 8009337001
• MDR Report Key: 17743502
• Report Number: 1220246-2023-07878
• Device Sequence Number: 4184761
• Product Code: LXH
• UDI-Device Identifier: 00888867116962
• UDI-Public: 00888867116962
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/13/2024

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: SLAP HAMMER
• Device Catalogue Number: AR-613-99
• Device Lot Number: 47321913
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2023
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2019
• 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