MAUDE Adverse Event Report: INTEGRA YORK, PA INC. SC IRIS SCS 4-1/2 CVD; M5 - GENERAL SURGERY

Catalog Number 5-SC-306

Device Problem Break (1069)

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

Event Date 09/22/2015

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 blade broke and came apart at screw during procedure.On (b)(6) 2015 customer reports physicians assistant was undermining a growth on the patients back.Blade did not fall into the small wound, no harm done to patient.

Manufacturer Narrative

11/20/15 integra investigation completed.Device manufacture date unknown.Method: failure analysis, device history evaluation.Results: failure analysis - failure analysis cannot be completed due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation.Device history evaluation - dhr review.Nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report / nonconforming material report history.Variance authorization / deviation history: there is no applicable variance authorization / deviation history.Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history.Corrective action preventive action history: there is no applicable corrective action preventive action history.Health hazard evaluation history: none.Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation.

Manufacturer Narrative

On 11/30/15 integra investigation completed.Manufacture date unknown.Method: failure analysis, device history evaluation.Results: failure analysis - one sc iris scissors returned in used condition, showing minimal wear and broken at the screw area.There is blackening at the break area (screw area), indicating that this started out as a stress fracture and with continued use and cleaning it caused the metal to break down and eventually causing it to break.This complaint is confirmed.Device history evaluation - nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report / nonconforming material report history.Variance authorization / deviation history: there is no applicable variance authorization / deviation history.Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history.Corrective action preventive action history: there is no applicable corrective action preventive action history.Health hazard evaluation history: none.Conclusion: this complaint has not been identified as a workmanship or material deficiency.

• Brand Name: SC IRIS SCS 4-1/2 CVD
• 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: 5160288
• MDR Text Key: 28980671
• Report Number: 2523190-2015-00108
• 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,Followup
• Report Date: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5-SC-306
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: 50 MO