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	05/16/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On 5/16/2024, it was reported by a sales representative via (b)(4) that (qty.3) of an ar-9165cdg univers revers universal baseplate impactor blue plastic tips was found to be broken after the case, during cleaning from an rtsa procedure on (b)(6) 2024.The issue did not disrupt the case or cause any negative impact on the patient, and the case was completed as normal.This was discovered after use, and no patient harm was reported.
Additional Manufacturer Narrative
Additional information.Complaint allegation is confirmed.One unpackaged ar-9165cdg batch number 052210 was received for investigation.Visual inspection revealed that the blue baseplate adapter had broken off.It was also noted that the laser marks were fading, and scratches were present on the shaft.No functional testing was performed due to the damage to the device.The reported condition is most likely caused by overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging.

• 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: 19510908
• Report Number: 1220246-2024-05557
• Device Sequence Number: 3456190
• Product Code: LXH
• UDI-Device Identifier: 00888867136731
• UDI-Public: 00888867136731
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 09/17/2024

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: 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: 05/16/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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