MAUDE Adverse Event Report: ARTHREX, INC. STOPCOCK,SINGLE,SPARE,FOR SYNERGY SHEATH; ACCESSORIES, ARTHROSCOPIC

Model Number STOPCOCK,SINGLE,SPARE,FOR SYNERGY SHEATH

Device Problem Material Fragmentation (1261)

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

Event Date 02/18/2021

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.

Event Description

It was reported that the surgeon fount something that may look like small red pieces of plastic in the knee joint during knee arthroscopy.They have examined everything, the only red is the red gasket of ar-3370-0001.The pieces were removed from patient.No harm or adverse event for patient, operator or third party was reported.The surgery was finished successfully with the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.

Manufacturer Narrative

The complaint cannot be confirmed.No device was returned for evaluation, and the allegation cannot be verified based on the customer provided photos.Although a photo was provided of what appears to be a red shaving, the photo quality is poor, and without physical evaluation, it is unable to be determined if this shaving originated from the gasket.No corresponding breakage can be observed in the photo provided of the ar-3370-0001.No change in harm was identified.

Manufacturer Narrative

Complaint confirmed.One unpackaged ar-3370-0001, batch 1586902 stopcock was received for investigation.Visual inspection under magnification identified chipping along the orange o-ring seal seated along the inner diameter of the stopcock.No fragments were returned for analysis.The cause remains undetermined, although a probable cause can be attributed to interference with mating instrumentation.

• Brand Name: STOPCOCK,SINGLE,SPARE,FOR SYNERGY SHEATH
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11436051
• MDR Text Key: 240341022
• Report Number: 1220246-2021-02678
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867029880
• UDI-Public: 00888867029880
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: STOPCOCK,SINGLE,SPARE,FOR SYNERGY SHEATH
• Device Catalogue Number: AR-3370-0001
• Device Lot Number: 1586902
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/18/2021
• Patient Sequence Number: 1