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

Model Number	7211006
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during setup for an arthroscopy a piece of hair was found inside the sterile package when opening it.The procedure was completed with a backup device and no delay or patient complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
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 a strand of long hair inside the sterile packaging.Functional evaluation was not performed because the visual inspection confirmed the complaint.The complaint has been confirmed and the root cause has been associated with 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 an isolated event.A review of the manufacturing process showed that an assembly step was not adequately performed.

• Brand Name: DYONICS 25 INFLW/OUTFLW FORK SUCTN (3)
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10483898
• Report Number: 1643264-2020-01030
• Device Sequence Number: 14301619
• Product Code: HRX
• UDI-Device Identifier: 03596010543592
• UDI-Public: 03596010543592
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2020

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 Expiration Date: 05/31/2022
• Device Model Number: 7211006
• Device Catalogue Number: 7211006
• Device Lot Number: 50803140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1