MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULA THREADED DISP 8.5 X 72MM; ACCESSORIES,ARTHROSCOPIC

Model Number 72200903

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during shoulder rotator cuff repair surgery, while opening the threaded cannula package, the product had a foreign body inside package.The malfunction was solved with a delay shorter than 30 minutes and no patient harm using a back up device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Internal complaint reference (b)(4).H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.An analysis of the customer provided images confirmed the part and batch numbers.There appeared to be a dark fiber of medium thickness within the packaging.A visual inspection revealed that two unopened packages of the same batch number were returned.In the corner of the first package, a thick, dark blue fiber could be seen.In the corner of the second package another dark fiber was found.There were not any packaging punctures or unsealed areas.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 a repeat issue.A review of the drawing found that packages must not contain particulates, debris, hair, or other foreign materials.The complaint was confirmed and the root cause was associated with manufacturing.Although every effort is made to control particulate in the controlled clean room, it is not possible to completely eliminate foreign matter in the area due to the human element.A correction in the form of a complaint notification has been issued to manufacturing management to mitigate future recurrences.

• Brand Name: CANNULA THREADED DISP 8.5 X 72MM
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11262779
• MDR Text Key: 229806505
• Report Number: 1219602-2021-00232
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010595119
• UDI-Public: 03596010595119
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2022
• Device Model Number: 72200903
• Device Catalogue Number: 72200903
• Device Lot Number: 903191001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 60