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	03/31/2025
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 (b)(6) 2025, it was reported by a sales representative via sems- (b)(4), an ar-9165cdg baseplate impactor assembly, had the flange off the blue impactor part, which was broken off.No patients were affected.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h1.Arthrex previously submitted this event as a reportable malfunction out of an abundance of caution.Upon further review and evaluation of associated risk documentation, it has been determined that this event does not meet the criteria of a reportable event under 21 cfr 803.
Event or Problem Description
Additional information was received on 05/05/2025: during a reverse total shoulder arthroplasty procedure on (b)(6) 2025, the instrument was found to be broken before the case began.The broken piece was located in the tray, and no fragments entered the patient.The procedure was successfully completed without incident, using an ar-9165cdg baseplate impactor assembly.There were no reported delays, and no additional anesthesia was required.The patient's bone quality was noted to be hard, but this did not affect the overall outcome.The patient experienced no adverse effects due to the issue.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-9165cdg batch number 052243 was received for investigation.Visual inspection noted that the blue baseplate adapter was broken/damaged.Functional testing wasn't 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.Refer to the investigation photos.The complaint allegation is confirmed.

• 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: 21858995
• Report Number: 1220246-2025-01522
• Device Sequence Number: 20013623
• Product Code: LXH
• UDI-Device Identifier: 00888867136731
• UDI-Public: (01)00888867136731(11)230503(10)052243
• 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,Followup
• Report Date (Section B): 08/13/2025

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: 052243
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 05/05/2025; 08/13/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/03/2025; 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• 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