ZIMMER-POPPEN RONGEUR 3416-563734 UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-05 for ZIMMER-POPPEN RONGEUR 3416-563734 UNKNOWN manufactured by Zimmer.

Event Text Entries

[1390] While physician was using the poppen ronquer to remove a ruptured intervertebral disc, the instrument came apart. Screw noted to be missing. Unable to locate missing screw. The facility submits this report pursuant to the provisions of 21 cfr part 803. This report is based on preliminary information received by facility which facility has not had the opportunity to investigate or verify prior to the reporting date. The facility has not conclusively determined the cause of this event. This report shall not be construed as an admission by this facility that it or any of its employees or affiliates caused or contributed to the incident described herein. In addition, the submission of this report shall not be construed as an admission that a reportable event has in fact occurreddevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: material degradation/deterioration. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device returned to manufacturer/dealer/distributor, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2133
• MDR Report Key: 2133
• Date Received: 1993-01-05
• Date of Report: 1992-09-14
• Date of Event: 1992-08-28
• Date Facility Aware: 1992-08-28
• Report Date: 1992-09-14
• Date Reported to FDA: 1992-09-14
• Date Reported to Mfgr: 1992-08-28
• Date Added to Maude: 1993-01-14
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ZIMMER-POPPEN RONGEUR
• Generic Name: POPPEN RONGEUR
• Product Code: EMH
• Date Received: 1993-01-05
• Model Number: 3416-563734
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• ID Number: UNKNOWN
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1978
• Manufacturer: ZIMMER

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-01-05