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

Catalog Number R1637

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2013

Event Type  malfunction  

Event Description

The dealer reports that the r1637 is in 3 pieces.On (b)(6) 2014, dealer reports the surgeon was performing a spinal fusion when the device broke and almost tore the dura, (b)(6) 2013.No harm to patient.X-ray was taken, nothing was found in the patient.Procedure was delayed 20 minutes.

Manufacturer Narrative

To date the device involved in the reported incident has not been received for eval.An investigation has been initiated based on the reported info.

• Brand Name: RUGGLES MICRO EJECTOR KERRISON RONGEURS BAR
• Type of Device: RONGEURS/KERRISONS/IVDS
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer (Section G): MILTEX, INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 315 enterprise drive; 6099366828
• MDR Report Key: 3726593
• MDR Text Key: 18856187
• Report Number: 2523190-2014-00003
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: R1637
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2014
• 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