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

Model Number	BASEPLATE IMPACTOR, ASSEMBLY
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-9165cdg univers revers¿ universal baseplate impactor batch number: 052233 was received for investigation.Visual evaluation noted that the blue baseplate adapter was damaged, and a fragment had broken off.It was further observed that the device had impaction marks on the shaft and the proximal end was damaged.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to misuse/mishandling due to the damage to the device.Refer to investigation photos.
Event or Problem Description
On (b)(6) 2024 it was reported by a sales representative via (b)(4) that an ar-9545-t15-01, (qty.4) of an ar-9545-t15-02, ar-9545-t15-03 driver shafts and an ar-9165cdg baseplate impactor assembly driver ends were twisted.Upon inserting the peripheral locking screws for the baseplate, the driver end would twist from the torque.This was discovered during the case with no patient harm.

• 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: 21410948
• Report Number: 1220246-2025-00544
• Device Sequence Number: 9345625
• Product Code: LXH
• UDI-Device Identifier: 00888867136731
• UDI-Public: (01)00888867136731(11)230116(10)052233
• 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
• Report Date (Section B): 02/19/2025

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: 052233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• 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