MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 25 INFLW/OUTFLW FORK SUCTN (3); ARTHROSCOPE

Catalog Number 7211006

Device Problems Fluid/Blood Leak (1250); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 09/17/2020

Event Type  malfunction  

Event Description

It was reported that the dyonics fork suction, had a fluid leakage from the cassette due to the transducer membrane that was missing.Incident occurred before the procedure.There was no delay and a back-up device was available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: h3, h6: the reported device, intended for use in treatment, was returned to the designated complaint unit for independent evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection of the returned device noted that the cassette is missing one transducer membrane.Functional evaluation was not performed because the visual inspection confirmed the complaint.The device would leak due to the missing transducer membrane.The complaint was confirmed and the root cause has been associated with a manufacturing error.A review of the device history records showed there were no indications to suggest that the lot did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of the manufacturing process showed that an assembly step was missed.A correction in the form of a complaint notification has been issued to manufacturing management to mitigate future recurrences.

• Brand Name: DYONICS 25 INFLW/OUTFLW FORK SUCTN (3)
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10656494
• MDR Text Key: 210637557
• Report Number: 1643264-2020-01452
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K051236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7211006
• Device Lot Number: 50865418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1