MAUDE Adverse Event Report: ARTHREX, INC. BASEPLATE IMPACTOR, ASSEMBLY; ORTHOPEDIC MANUAL SURG INSTR

Model Number	BASEPLATE IMPACTOR, ASSEMBLY
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 10/22/2024, it was reported by a sales representative via (b)(6) that an ar-9165cdg univers revers¿ universal baseplate impactors tip broke off.This occurred during a recent case.
Event or Problem Description
Additional information was received on 10/28/2024 by a sales representative who stated that the event occurred on 10/17/2024.The procedure being performed was an rtsa.The blued piece of the device broke while impacting.No photos were taken.An arthrex agent was present during the procedure.The patient's bone quality was good.A reamer 1 and a final reamer were used to prepare the bone socket.Al fragments were removed from the patient.The procedure was completed as planned without any delays or need for additional anesthesia.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-9165cdg batch number 052215 was received for investigation.Upon visual evaluation, it was found that the instrument's baseplate adapter was broken off.Functional testing was not performed due to the damage of the device.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• Brand Name: BASEPLATE IMPACTOR, ASSEMBLY
• 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: 20612446
• Report Number: 1220246-2024-08404
• Device Sequence Number: 15463550
• Product Code: LXH
• UDI-Device Identifier: 00888867136731
• UDI-Public: (01)00888867136731(11)220712(10)052215
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2025

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: BASEPLATE IMPACTOR, ASSEMBLY
• Device Catalogue Number: AR-9165CDG
• Device Lot Number: 052215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 10/28/2024; 01/06/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 12/20/2024; 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• 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