MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX AR-300,HANDPIECE; POWERED SURG ORTHOPEDIC INSTR

Model Number	ARTHREX AR-300,HANDPIECE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
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
It was reported that the pins broke.The problem was noticed after the surgery.There was no harm for the patient, operator or third party reported.There was no case involvement reported.No further information received.
Additional Manufacturer Narrative
The reported event was confirmed.The manufacturer evaluation revealed a missing retaining pin which guides the battery casing (ar-300lbh) and prevents the pins of the electronics from being bent or broken.Due to the missing retaining pin, the pin of the electronic is probably broken.The most likely cause is attributed to improper device handling.

• Brand Name: ARTHREX AR-300,HANDPIECE
• Common Device Name: POWERED SURG ORTHOPEDIC 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: 19345734
• Report Number: 1220246-2024-03475
• Device Sequence Number: 2608133
• Product Code: HWE
• UDI-Device Identifier: 00888867099357
• UDI-Public: 00888867099357
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2024

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: ARTHREX AR-300,HANDPIECE
• Device Catalogue Number: AR-300
• Device Lot Number: 11265427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown