MAUDE Adverse Event Report: INTEGRA YORK, PA INC. IRIS SCS 4-1/2 CVD; N/A

Catalog Number 360101

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

The or was using a pair of scissors on a finger.When finished the doctor noticed a small tip missing from the scissors.They x-rayed the finger and the piece was in the wound.They had to reopen the wound then re suture.On (b)(6) 2016 no further information available.

Manufacturer Narrative

On 2/3/16 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - scissors were returned in used condition, showing a green tape marking.The returned scissor showing wear, staining and a broken tip.Upon visually inspecting the instrument, it is noticed that there is staining at the hinge area; and the tip is broken.It is also noticed that there is black staining where the breakage is.This is the result from detergents used to clean the instrument.The black acid staining can be caused by low ph (less than six) during autoclaving.This can weaken the metal causing breakage.This type of damage is typically the result of improper processing.Condition of the instrument reveals improper care.The complaint report is confirmed; damaged worn.Device history evaluation - dhr review was completed with all history available.Nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: there is no applicable variance authorization / deviation history.Engineering change order/manufacturing change order history: none.Corrective action preventive action history: none.Health hazard evaluation history: none.Conclusion: the root cause has not been identified as a workmanship or material deficiency.

• Brand Name: IRIS SCS 4-1/2 CVD
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5408000
• MDR Text Key: 37433920
• Report Number: 2523190-2016-00011
• Device Sequence Number: 0
• Product Code: HNF
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2016
• Device Operator: Health Professional
• Device Catalogue Number: 360101
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention