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

Model Number	72200905
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during shoulder surgery, a 7.0 mm cannula cleartrac was opened and before using it, it was noticed that the rubber around the tip was broken.A s+n backup was used to completed the procedure.There was no delay and no patient injury or other 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 722000905 7.0 x 72mm clear-trac threaded cannulas, intended for use in treatment, have not been returned for evaluation.Without the reported product, a visual evaluation cannot be performed and the customers complaint cannot be confirmed.The information provided states, ¿during shoulder surgery, the q-fix all suture anchor wouldn't deploy; the site was drilled correctly using the appropriate drill guide¿.However, this is an acknowledged failure mode has been evaluated and is being monitored.A review of the complaint and manufacturing records was performed and indicated similar allegations for the lot number reported.

• Brand Name: CANNULA CLEARTRAC THREADED 7.0 X 72MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10384081
• Report Number: 1219602-2020-01214
• Device Sequence Number: 2942067
• Product Code: NBH
• UDI-Device Identifier: 03596010595133
• UDI-Public: 03596010595133
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2020

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: 05/01/2022
• Device Model Number: 72200905
• Device Catalogue Number: 72200905
• Device Lot Number: 905190511
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 09/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1