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

Model Number	014719
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during set-up.The cl-tr third cann 5mm/76mm ltx free (10) b had one obturator missing from the package.Instead, two trocars were packed.The procedure was successfully completed without delay using a back-up device.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
Correct aware of the initial mdr sent on 21-jan-2021 was 28-dec-2020.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that the device was not returned in its original packaging.There were two trocars and a cannula present, but the obturator was missing.The tip protectors were not present on either trocar.There was no debris.A review of the device records showed there were no indications to suggest that the product 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 drawing found that the trocar, obturator, and cannula were specified to be packaged in the same pouch.The trocar was equipped with a tip protector.The complaint was confirmed, but the root cause could not be established since the set was not returned in unmodified packaging.Factors that could have contributed to the reported event include mix up of sets, re-use of device leading to mixed products, or a packaging problem prior to arrival at the customer site.

• 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: 11208349
• Report Number: 1219602-2021-00183
• Device Sequence Number: 11904224
• Product Code: NBH
• UDI-Device Identifier: 03596010026194
• UDI-Public: 03596010026194
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 02/25/2021

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: 11/11/2024
• Device Model Number: 014719
• Device Catalogue Number: 014719
• Device Lot Number: 2044697
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 01/24/2021; 02/23/2021
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 02/02/2021; 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1