MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ELITE PASS, LONG BITE, WITH RATCHET; ACCESSORIES,ARTHROSCOPIC

Model Number 72201840

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2015

Event Type  malfunction  

Manufacturer Narrative

Visual assessment of the device confirmed the reported complaint.The upper jaw is free from the device.Dimensional assessment of the components that were returned met print specifications.The upper jaw was not returned.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.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 during a rotator cuff repair the healthcare professional when to grasp some tissue and the top of the elite pass broke off.The piece was retrieved with graspers and a backup was used to finish the case.There was no reported patient injury or surgical complication.No other complications were noted.

• Brand Name: ELITE PASS, LONG BITE, WITH RATCHET
• 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: 5967773
• MDR Text Key: 55573666
• Report Number: 1219602-2016-00809
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2015

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 Model Number: 72201840
• Device Catalogue Number: 72201840
• Device Lot Number: T214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/24/2015
• Initial Date FDA Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1