ACUFEX MICROSURGICAL MM INTERFERENCE SCREW DRIVER 013610

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-20 for ACUFEX MICROSURGICAL MM INTERFERENCE SCREW DRIVER 013610 manufactured by Acufex Microsurgical.

Event Text Entries

[18443605] During surgical procedure - arthroscopy acl reconstruction to left knee, acufex 7mm cannulated interference screw driver was used to tighten screw. X-ray one week post-procedure showed a metal fragment in knee. Second procedure 4/7/92 to remove metal object, extended procedure due to difficulty. Metal object was found to be section from scresdriver tip. Device 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. 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: material degradation/deterioration, telemetry failure. Conclusion: 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: 3699
• MDR Report Key: 3699
• Date Received: 1992-07-20
• Date of Report: 1992-04-14
• Date of Event: 1992-03-31
• Date Facility Aware: 1992-04-07
• Report Date: 1992-04-14
• Date Reported to Mfgr: 1992-04-14
• 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: ACUFEX MICROSURGICAL MM INTERFERENCE SCREW DRIVER
• Generic Name: INTERFERENCE SCREW DRIVER
• Product Code: GZX
• Date Received: 1992-07-20
• Catalog Number: 013610
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-AUG-91
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3445
• Manufacturer: ACUFEX MICROSURGICAL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-20