MAUDE Adverse Event Report: INTEGRA YORK, PA INC. RUGGLES MICRO KERRISON RONGEUR - THIN FOOTPLATE; N/A

Catalog Number RN4853

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

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

Event Date 12/09/2015

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 the kerrisons do not cut, tears tissue.(b)(6) 2015 customer reports that "the doctor was performing a microsurgical discectomy and was biting soft tissue with the device.No harm done but the case took longer due to tearing of the tissue as opposed to cutting.".

Manufacturer Narrative

On 12/16/1205 integra investigation completed.Dates of manufacturer: 1/2015 (1ea) 5/2015 (1ea).Method: failure analysis, device history evaluation.Results: failure analysis: two ruggles micro kerrisons returned in used condition, one has green with white dots tape marking and the other has no markings.The two returned kerrisons have been evaluated with the designated testing material that revealed the rongeur is cutting cleanly and there was no catching when pressure was applied to cut the testing material.Device history evaluation - dhr complete with all available history.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 complaint report has been unconfirmed; testing within specification.

• Brand Name: RUGGLES MICRO KERRISON RONGEUR - THIN FOOTPLATE
• 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: 5306820
• MDR Text Key: 33771249
• Report Number: 2523190-2015-00145
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• PMA/PMN Number: K150428
• 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: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RN4853
• Device Lot Number: RN4853 X2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 56 YR