MAUDE Adverse Event Report: ARTHREX, INC. SAW ATTACHMENT-SAG MINIMAL INVASIVE CUTS; POWERED SURG ORTHOPEDIC INSTR

Model Number	SAW ATTACHMENT-SAG MINIMAL INVASIVE CUTS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
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 saw attachment becomes loose while sawing.Due to that issue, the saw blade falls out of the attachment.There was no harm for patient, operator or third party reported.This was noticed before the surgery.No further information received.Update dw: 16-feb-2024: further information were provided that apparently the event occurred during use.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 it was reported that the saw attachment becomes loose while sawing.Due to that issue the saw blade falls out of the attachment.The reported event was not confirmed.The manufacturer evaluation did not reveal any problems with this device.

• Brand Name: SAW ATTACHMENT-SAG MINIMAL INVASIVE CUTS
• 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: 18835638
• Report Number: 1220246-2024-01291
• Device Sequence Number: 7294408
• Product Code: HWE
• UDI-Device Identifier: 00888867111103
• UDI-Public: 00888867111103
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• 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: SAW ATTACHMENT-SAG MINIMAL INVASIVE CUTS
• Device Catalogue Number: AR-600SAGMIS
• Device Lot Number: 14939074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• 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