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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
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 12/04/2024 it was reported by a sales representative via sems-(b)(4) that (qty.(b)(4)) of an ar-9165cdg baseplate impactor assembly drill guide and impactors had damaged tips.This was discovered during the case.Another device was used to complete the case with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-9165cdg univers revers¿ universal baseplate impactor batch number 052233 was received for evaluation.Visual inspection identified that the blue baseplate adapter had broken off.It was noted that the laser marks were fading.Functional testing cannot be performed as the device was received damaged.The most likely cause of the reported failure is wear and damage due to repeated use and/or reprocessing.

• 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: 21036026
• Report Number: 1220246-2024-09112
• Device Sequence Number: 18272930
• Product Code: LXH
• UDI-Device Identifier: 00888867136731
• UDI-Public: (01)00888867136731(11)230116(10)052233
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 02/14/2025

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: BASEPLATE IMPACTOR, ASSEMBLY
• Device Catalogue Number: AR-9165CDG
• Device Lot Number: 052233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/14/2025
• 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