MAUDE Adverse Event Report: ARTHREX, INC.; ARTHROSCOPE

Lot Number TUBING

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 05/14/2021

Event Type  malfunction  

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 Description

It was reported that the pump was being used for an ankle arthroscopy and orif ankle fracture case.The pump was stopping and being restarted; it then pumped excessive fluid into the patient and the case was aborted.The patient did not require additional hospitalization and the case will be rescheduled.Patient is female, (b)(6) years.

Manufacturer Narrative

Complaint was confirmed based on the picture provided.The device was not returned for evaluation.Among the most common causes for this type of issue/occurrence are (1) unplugging and plugging the pressure line connector into the arthroscopy pump, thereby creating a pressure decay on the pump or (2) spiking the bags of fluid and allowing that fluid to migrate through the tubing before plugging the pressure line connector into the pump.

• Brand Name: UNK
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12075323
• MDR Text Key: 258642890
• Report Number: 1220246-2021-03316
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K083707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: TUBING
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 06/28/2021
• Supplement Dates Manufacturer Received: 06/08/2021
• Supplement Dates FDA Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR