D242-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-31 for D242-01 manufactured by Depuy.

Event Text Entries

[2745] Chisel broke during joint replacement surgery. The shaft measured 6. 16 mm which tapered to 11 after the bend. The break occurred at approx. 23. 2 mm from center of the bendinvalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. 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. Invalid data - whether device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: component failure, end of life - premature. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4799
• MDR Report Key: 4799
• Date Received: 1992-07-31
• Date of Report: 1992-02-24
• Date of Event: 1992-02-06
• Date Facility Aware: 1992-02-06
• Report Date: 1992-02-24
• Date Reported to Mfgr: 1992-02-24
• Date Added to Maude: 1993-06-07
• 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

• Generic Name: CHISEL
• Product Code: EML
• Date Received: 1992-07-31
• Model Number: D242-01
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 4515
• Manufacturer: DEPUY

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-31