MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CL-TR THRD CANN 5MM/76MM LTX FREE (10) B; ACCESSORIES,ARTHROSCOPIC

Catalog Number	014719
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during set up in an arthroscopic surgery, when the customer opened the package of the "clear-trac cannula threaded 5x76mm", it was found that the tip of the device was already chipped.A backup device was available to complete the procedure.No procedural delay and no patient injuries 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
H10 h3, h6: one piece of 014719 clear trac cannula kit used in treatment, was not returned for evaluation.The kit is sold as a set of five cannulas with two obturators each.They are individually pouched and also packaged in a larger shelf carton.It is unknown when or where the damage reported occurred.Per instructions for use: prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device.Complaint history review indicated a similar allegation for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.No root cause related to the manufacturing was confirmed.Product met specifications upon release to distribution.
Additional Manufacturer Narrative
One piece of 014719 clear trac cannula kit used in treatment, was returned for evaluation.The kit is sold as a set of ten cannulas with two obturators each.They are individually pouched and also packaged in a larger shelf carton.Per instructions for use: prior to use, inspect the device to ensure it is not damaged.The cannula was not chipped but was returned sliced at the distal tip.There was still bio matter lodged in the slice.The cannula had an encounter with bone other hard matter.The sliver assumed to be related, was not.It was a shaving from the trocar from the trimming / smoothing process that did not get air blown off the trocar or clung due to static.Complaint history review indicated a similar allegation for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.No root cause related to the manufacturing was confirmed.Product met specifications upon release to distribution.

• Brand Name: CL-TR THRD CANN 5MM/76MM LTX FREE (10) B
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10135996
• Report Number: 1219602-2020-00865
• Device Sequence Number: 11710204
• Product Code: NBH
• UDI-Device Identifier: 03596010026194
• UDI-Public: 3596010026194
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 09/05/2020

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: 10/30/2023
• Device Catalogue Number: 014719
• Device Lot Number: 50767291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 07/01/2020; 07/01/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 07/05/2020; 09/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1