MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUEPASS NEEDLE,SINGLE PACK,STERILE BX 5; ACCESSORIES, ARTHROSCOPIC

Catalog Number 72203793

Device Problem Break (1069)

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

Event Date 10/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A review of the device history records was performed which confirmed no inconsistencies.A complaint history review identified no additional complaints for this manufactured lot.(b)(4).

Event Description

Report of a rotator cuff repair surgery where the needle allegedly broke during the passage through the rotator cuff.There was no reported patient injury as the result of the event and it is unknown whether there was any surgical delay resulting from the reported event.

Manufacturer Narrative

The initial report mistakenly indicated that the device was returned for evaluation.The subject device was not returned, therefore cannot be visually or functionally evaluated.

• Brand Name: TRUEPASS NEEDLE,SINGLE PACK,STERILE BX 5
• 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: james gonzales ; 130 forbes boulevard; mansfield 02048 ; 5123585706
• MDR Report Key: 5304284
• MDR Text Key: 34331371
• Report Number: 1219602-2015-01259
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/24/2016

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: 03/24/2019
• Device Catalogue Number: 72203793
• Device Lot Number: 50502455
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/10/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2015
• Initial Date FDA Received: 12/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2014
• 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