MAUDE Adverse Event Report: ARTHREX, INC. DRILL SAW SPORTS 400; POWERED SURG ORTHOPEDIC INSTR

Model Number	DRILL SAW SPORTS 400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
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 during an anterior cruciiate ligament btb surgery two pins broke off inside attachment head outside the patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully with the same device anyway.It was not necessary to switch the surgical technique or do a second surgery.
Event or Problem Description
Update dw 26-mar-2024: further information were provided that after disconnecting the attachment form hand piece, two metal pins fell out.
Additional Manufacturer Narrative
It was reported that during an anterior cruciate ligament btb surgery two pins broke off inside attachment head outside the patient.The reported event was confirmed.The manufacturer evaluation revealed to broken driver pins.A broken pin is most likely caused by placing too much load on the driver during use.

• Brand Name: DRILL SAW SPORTS 400
• 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: 18981045
• Report Number: 1220246-2024-01661
• Device Sequence Number: 12386570
• Product Code: HWE
• UDI-Device Identifier: 00888867223318
• UDI-Public: 00888867223318
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2024

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: DRILL SAW SPORTS 400
• Device Catalogue Number: AR-400
• Device Lot Number: 15127896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 03/26/2024; 07/29/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 05/20/2024; 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2023
• 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