MAUDE Adverse Event Report: INTEGRA YORK, PA INC. RUGGLES CUSHING IVD - STRAIGHT - 9 INCHES - 2MM; N/A

Catalog Number RN5912H

Device Problem Break (1069)

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

Event Date 06/24/2016

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 that while removal of disc material the instrument was broken.On (b)(6) 2016 customer reports that a ctvs micro-discectomy was being performed.The jaw broke but no parts broke off device.X-ray taken to assure no parts left in patient.First time use for the device, no harm done confirmed.

Manufacturer Narrative

On 9/15/2016 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - rongeur was returned in used condition, not showing any unusual markings and a broken pin.Upon visually inspecting the instrument, it is noticed that the pin is missing where the jaw is located and the tip is misaligned.Without knowing how the instrument was handled and maintained during use, the cause is undetermined.The complaint report 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: RUGGLES CUSHING IVD - STRAIGHT - 9 INCHES - 2MM
• 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: 5917131
• MDR Text Key: 53567230
• Report Number: 2523190-2016-00138
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RN5912H
• Device Lot Number: 100161-1507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/12/2016
• Initial Date FDA Received: 08/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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: 56 YR