MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHROSCOPE ACLV 2.7X30D SHORT

Catalog Number 7205682

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

User facility medwatch report received indicates that when the orthopedic hand surgeon took the scope out and put it back into the patient's wrist, he could not see very well.Scope was sent out for evaluation and repair.Facility biomed examined the scope and noted that the tiny glass/clear cover that goes over the lens, was missing.Md was notified and disclosure was done with the patient.Md to continue to follow up with the patient.Md determined the piece is so small it would not be able to be located/noted on x-ray and more than likely would have been washed out of the patient during copious irrigation that took place during the procedure.There have been no complaints of pain/issues from the patient.

Manufacturer Narrative

Visual inspection and functional testing could not be performed because the device in question will not be returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product to look at.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.Our quality department will continue to monitor for trends.No further investigation is required.Evaluation codes updated to indicate that manufacturing review was performed.(b)(4).

• Brand Name: ARTHROSCOPE ACLV 2.7X30D SHORT
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: james gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5780589
• MDR Text Key: 49126193
• Report Number: 3003604053-2016-00031
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K962075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7205682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other