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	04/15/2024
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 04/15/2024, it was reported by a distributor via (b)(4) that an ar-400 handpiece motor fell apart.This occurred during a case with no effect on the patient.
Additional Manufacturer Narrative
One unpackaged ar-400 handpiece serial number: (b)(6) was received for investigation.Visual evaluation of the returned device noted that the device was damaged, the gear unit was observed to be broken.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to misuse/mishandling due to the damage to the device.Refer to investigation photos.Complaint allegation is confirmed.
Event or Problem Description
On 05/07/2024, additional information was provided by a distributor via email who stated that the procedure performed was an anterior cruciate ligament reconstruction, bone-tendon-bone technique.At the time of use the saw attachment did not fit properly and was unsuccessful in use.Photos were taken and are attached.No fragments remained in the patient and to complete the procedure, the bone-tendon-bone technique was changed and semitendinosus graft was taken out.

• 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: 19294128
• Report Number: 1220246-2024-03131
• Device Sequence Number: 12933475
• Product Code: HWE
• UDI-Device Identifier: 00888867223318
• UDI-Public: 00888867223318
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2024

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: 15015989
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 12/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• 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