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

Catalog Number RD4824M

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Event Description

It was reported that patient in middle of surgery and item was missing screw.Device was not in contact with patient.No patient injury/death was alleged or medical intervention was required.Patient was prepped for surgery.Delay in surgery was unknown.

Manufacturer Narrative

On 8/17/16 integra investigation completed.Manufacture date unknown.Method: failure analysis, device history evaluation results: failure analysis - a kerrison rongeur was returned with extreme wear, damaged screw on handle, repair markings on spring, dull tip and missing screw on top rail.Upon further investigation, it is noticed that the screw that is intact on the handle has been tampered with and the screw on the top rail is missing.This missing screw could have happened during sterilization/processing of the product and also not knowing the age or how the instrument was handled, could also have been a factor.The complaint report is confirmed.Device history evaluation - nonconforming product report / nonconforming material report history: none.Corrective action preventive action history/ correction: none.Variance authorization / deviation history: none.Engineering change order/manufacturing change order history: there are no applicable engineering change order/ manufacturing change order history.Health hazard evaluation history: none.Conclusion: root cause has not been identified as a workmanship or material deficiency.

• Brand Name: RUGGLES DIAMOND MEDIUM KERRISON RONGEUR - THIN F
• 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: 5880905
• MDR Text Key: 53063275
• Report Number: 2523190-2016-00131
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RD4824M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2016
• 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: Reuse
• Patient Sequence Number: 1