MAUDE Adverse Event Report: INTEGRA YORK, PA INC. SC GRADLE SCISSORS 3-3/4; M5 - GENERAL SURGERY

Catalog Number 18-SC-1652

Device Problem Break (1069)

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

Event Date 10/14/2015

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

Customer initially reports device broke in half.On (b)(6) 2015 customer reports that doctor was performing mohs micrographic surgery for skin cancer when scissor blade broke, no harm to the patient.

Manufacturer Narrative

On 11/11/2015 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - scissors returned in used condition, not showing any unusual markings.The returned scissors showing wear and a broken blade.The scissors are broken at the hinge area, per end users complaint the event happened during a procedure.Without knowing how much pressure was used to the scissor while in use, the cause is undetermined.Looking further into the area of breakage, it is noticed that there is black staining.This type of damage usually occurs when the instrument is improperly processed.Condition of the scissor 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: none.Engineering change order/manufacturing change order history: none.Corrective action preventive action history: there is no applicable corrective action preventive action history.Health hazard evaluation history: none.Conclusion: the root cause has not been identified as a workmanship or material deficiency.

• Brand Name: SC GRADLE SCISSORS 3-3/4
• Type of Device: M5 - GENERAL SURGERY
• 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: 5240762
• MDR Text Key: 31786514
• Report Number: 2523190-2015-00112
• 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: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 18-SC-1652
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• 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 Age: 62 YR