MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULA CLEARTRAC THREADED 7.0 X 72MM; ACCESSORIES,ARTHROSCOPIC

Model Number	72200905
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, the cannula had small pieces of plastic.This device was used in the patient and the plastic piece fell off into the patient but it was retrieved from.The procedure was completed with a back up device with no delay or patient injury reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that during a shoulder procedure, the cannula had small pieces of plastic.This device was used in the patient and the plastic piece fell off into the patient but it was retrieved from.The procedure was completed with a back up device with no delay or patient injury reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3, h6: one 72200905 threaded disposable cannula product used for treatment, was returned for evaluation.This product has a j-lock channel on the cannula tube top that mates and twist locks snugly with the cannula head component.The tube top was slightly loose upon receipt.There was a small piece of foam returned.Upon opening the cannula top, the source was confirmed.The fragment came from the inner foam seal of the cannula top.The fragment was poked through and ripped off the foam seal by either pressure or use of a sharp instrument.Product met specifications upon release to distribution.

• Brand Name: CANNULA CLEARTRAC THREADED 7.0 X 72MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9734899
• Report Number: 1219602-2020-00273
• Device Sequence Number: 14258196
• Product Code: NBH
• UDI-Device Identifier: 03596010595133
• UDI-Public: 03596010595133
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2020

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: 06/27/2022
• Device Model Number: 72200905
• Device Catalogue Number: 72200905
• Device Lot Number: 905190627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 04/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR