MAUDE Adverse Event Report: INTEGRA YORK, PA INC. JARIT-KERRISON RONG 7 4MM 40D; N/A

Catalog Number 280062

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

Customer initially reports device is broken.On (b)(6) 2016 dealer reports neurosurgery being performed, device broke at handle, no parts fell off, no harm to patient, no further information available.

Manufacturer Narrative

On 3/16/1206 integra investigation completed.Method : failure analysis, device history evaluation results : failure analysis - no return of device for evaluation.Device history evaluation - dhr was based on all history.Nonconforming product report / nonconforming material report history: no applicable nonconforming product reports/ nonconforming material report history.Variance authorization / deviation history: none engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history.Corrective action preventive action history: none health hazard evaluation history: none conclusion : root cause could not be determined due to the instrument not being returned for evaluation.

• Brand Name: JARIT-KERRISON RONG 7 4MM 40D
• 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: 5454828
• MDR Text Key: 38825440
• Report Number: 2523190-2016-00013
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 280062
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2016
• 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