MAUDE Adverse Event Report: ARTHREX, INC. SAW ATTACHMENT-SAGITTAL; POWERED SURG ORTHOPEDIC INSTR

Model Number SAW ATTACHMENT-SAGITTAL

Device Problems Use of Device Problem (1670); Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2023

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not yet 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 Description

It was reported that during a knee arthroplasty, when the saw blade met hard bone, it sort of danced on the bone instead of cutting into the bone.The machine turned up the power but it didn¿t cut.According to the surgeon, no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.

Manufacturer Narrative

Additional information: h6 the reported event was not confirmed.The manufacturer evaluation did not reveal any problems with this device.

• Brand Name: SAW ATTACHMENT-SAGITTAL
• Type of Device: 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: emily shafer ; 8009337001
• MDR Report Key: 17921879
• MDR Text Key: 325511405
• Report Number: 1220246-2023-08170
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867111073
• UDI-Public: 00888867111073
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SAW ATTACHMENT-SAGITTAL
• Device Catalogue Number: AR-600SAG
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1