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

Catalog Number 101300

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

Dealer initially reports this instrument tip was broken during e.N.T surgery.No broken parts inside the patient.No harm done.On (b)(46) 2016 dealer has no new information.

Manufacturer Narrative

On 5/10/16 integra investigation completed.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.Unconfirmed/no return of device for evaluation.Device history evaluation - dhr review: 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: none.Health hazard evaluation history: none.Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation.

Manufacturer Narrative

On 11/8/16 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - scissors in used condition, not showing any unusual markings.The returned scissors showing wear, discoloration and broken tips.While visually inspecting the instrument, it is noticed the hinge area has some minimal discoloration and the tips are broken.The complaint is confirmed; device history evaluation - dhr review.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:none.Health hazard evaluation history: none.Conclusion: the root cause has not been identified as a workmanship or material deficiency.

• Brand Name: CARB-EDGE IRIS SCS 4-1/2 STR
• 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: 5515109
• MDR Text Key: 40836855
• Report Number: 2523190-2016-00040
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101300
• Device Lot Number: 8859113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2016
• 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: Unknown
• Patient Sequence Number: 1