SCTW-008L

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 SCTW-008L manufactured by Osteonics.

Event Text Entries

[2949] Left total wrist prosthesis removed and replaced due to failure. Cause of failure on pathologist's examination was that the high density polyethylene hinge showed wear. The prosthesis measured 8. 5 cm by 1. 7 x 0. 5 cminvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding 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. Invalid data - regarding whether event presents imminent hazard. 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: end of life - premature, material degradation/deterioration. Conclusion: device failure directly contributed to event. Certainty of device as cause of or contributor to event: unknown (cannot determine). 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: 4730
• MDR Report Key: 4730
• Date Received: 1992-07-31
• Date of Report: 1992-07-27
• Date of Event: 1992-04-06
• Date Facility Aware: 1992-04-06
• Report Date: 1992-07-27
• Date Reported to Mfgr: 1992-07-27
• 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

• Product Code: KIG
• Date Received: 1992-07-31
• Catalog Number: SCTW-008L
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 4446
• Manufacturer: OSTEONICS

Patients

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