MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIV CANN 5MM/76MM LTX FREE (10) BLUE; ACCESSORIES,ARTHROSCOPIC

Catalog Number 012405

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/21/2014

Event Type  malfunction  

Manufacturer Narrative

Visual inspection confirmed the reported complaint.The device was received with a portion of the distal tip broken off.The broken tip was returned with the device.A visual evaluation of the device via 40x magnification identified impact marks on the broken end of the device.The impact marks are consistent with damage from a hard, sharp surface.A review of the device history records did not identify any additional discrepancies during manufacture.No additional complaints are on file for this lot and reported failure mode.There are no indications that would suggest that the device did not meet product specifications upon release into distribution.

Event Description

It was reported that the device broke during a shoulder arthroscopy.The broken piece was removed from the surgical site and the procedure was successfully completed using a back-up device.No patient injury or other complications were reported.

• Brand Name: UNIV CANN 5MM/76MM LTX FREE (10) BLUE
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5966940
• MDR Text Key: 55670311
• Report Number: 1219602-2016-00792
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/21/2014

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: 03/31/2016
• Device Catalogue Number: 012405
• Device Lot Number: 50374305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2014
• Initial Date FDA Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1