MCELROY SPREADERS 915598

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 MCELROY SPREADERS 915598 manufactured by Smith & Nephew Richard, Inc..

Event Text Entries

[3133] While tightening the blade in place, the head of the screw broke off and dropped into the operative site. The screw was retrieved with no sequelae to the patient. The screw broke with 3. 2 mm from the distal end. The break appears to be due to wear and tear. Device not labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Device not serviced in accordance with service schedule. 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, visual examination. Results of evaluation: component failure, design - inadequate, design - human factors. Conclusion: device failed during assembly, device failure directly caused event. Certainty of device as cause of or contributor to event: yes. 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: 4745
• MDR Report Key: 4745
• Date Received: 1992-07-31
• Date of Report: 1992-03-11
• Date of Event: 1992-03-03
• Date Facility Aware: 1992-03-03
• Report Date: 1992-03-11
• Date Reported to Mfgr: 1992-03-11
• 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

• Brand Name: MCELROY SPREADERS
• Generic Name: SPREADER BARS
• Product Code: CBG
• Date Received: 1992-07-31
• Model Number: NA
• Catalog Number: 915598
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 4461
• Manufacturer: SMITH & NEPHEW RICHARD, INC.

Patients

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