MAUDE Adverse Event Report: INTEGRA YORK, PA INC. RUGGLES STEALTH MICRO EJECTOR KERRISON RONGEURS; RONGEURS/KERRISONS/IVDS

Catalog Number RB4893

Device Problem Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation completed on 06feb2018.The dhr review had no applicable engineering change order/manufacturing change order history.There were two ruggles ronguers, returned used/processed showing wear, staining.The rongeurs were tested for dullness using carton 250 g/m2.Upon testing, both cut as designed.The complaint report cannot be confirmed, due to the instrument testing within defined specification.Linked to mfg report number: 2523190-2018-00024.

Event Description

This report is 2 of the 2 complaints.On the second week of (b)(6), the customer reported that a rb4892e ruggles stealth micro ejector kerrison rongeurs stopped cutting within 3-4 months of usage.Additional information received on (b)(6) 2018 indicating that the patient was prepped for laminectomy and that there was a 30 min delay because they had to open a different product.There was no patient injury reported.

• Brand Name: RUGGLES STEALTH MICRO EJECTOR KERRISON RONGEURS
• Type of Device: RONGEURS/KERRISONS/IVDS
• 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: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7278556
• MDR Text Key: 100520039
• Report Number: 2523190-2018-00025
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RB4893
• Device Lot Number: 100180-1706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Date Manufacturer Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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