4MM D.D. TAPERED BURR 4 MM O.D. 9751

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-15 for 4MM D.D. TAPERED BURR 4 MM O.D. 9751 manufactured by Concept, Inc..

Event Text Entries

[20519263] While the physician was doing an arthrodesis of the left ankle he began to use the burr on the talar and tibial surfaces, in preparation for the fixation. The burr when it hit hard bone would slow down. In continuing touse the burr the physician noted a hard area and eventually the apparatus stopped and it would not start. He checked the connection, felt that it could have possibly been loose, and he tried to start the burr again. It would not work. He checked the connection again and then looked at the burr and stem in the ankle. Ahemostat was used to remove the burr and the stem and there was no adverse outcome to patientdevice 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: actual device involved in incident was evaluated, a device from same lot was evaluated, visual examination, other. Results of evaluation: other. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device temporarily removed from service, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3698
• MDR Report Key: 3698
• Date Received: 1992-07-15
• Date of Report: 1991-12-30
• Date of Event: 1991-12-16
• Date Facility Aware: 1991-12-19
• Report Date: 1991-12-30
• Date Reported to FDA: 1991-12-30
• Date Reported to Mfgr: 1991-12-30
• Date Added to Maude: 1993-04-30
• 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: 4MM D.D. TAPERED BURR
• Generic Name: INTRA ARC ARTHROSCOPY BLADE SYSTEM
• Product Code: KWK
• Date Received: 1992-07-15
• Model Number: 4 MM O.D.
• Catalog Number: 9751
• Lot Number: 52582
• ID Number: US PAT. NO. 4, 842578
• Operator: OTHER
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3444
• Manufacturer: CONCEPT, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-15