SINGLE CLAMP WITH T-TYPE HANDLE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-24 for SINGLE CLAMP WITH T-TYPE HANDLE * manufactured by Zimmer, Inc..

Event Text Entries

[17566269] Patient was being transported in bed, foot of the bed first. Patient was in a bed with orthopedic traction attached. As patient was being wheeled through the door, the top cross bar of the traction bumped the door frame, which caused the perpendicular suspension piece to fall onto the patient's shins. The part that fell was wrapped in bandaging from previous use; weighed approximately 20 lbs (estimated). This fell on the legs, just below the knees. Once it fell, the part was immediately lifted from shins and remainder of traction was removed from the bed. X-rays were ordered; preliminary showed possible non-displaced fracture; however, follow-up x-ray confirmed no acute fracture identified. The type of device is no longer produced with the t-type handle. This product is >10 years old. We are unable to find the specific product number for the actual part in question, as the part is no longer manufactured or available by zimmer. The currently available "single clamp 9-inch bar" by zimmer has a circular handle in lieu of the t-type handle. The product number for the currently available product with the circular hand is product #: 00-0640-004-00 zimmer code: 9.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3539384
• MDR Report Key: 3539384
• Date Received: 2013-12-24
• Date of Report: 2013-12-10
• Date of Event: 2013-10-03
• Report Date: 2013-12-10
• Date Reported to FDA: 2013-12-24
• Date Reported to Mfgr: 2013-12-27
• Date Added to Maude: 2013-12-27
• 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: 3
• Health Professional: 3
• Initial Report to FDA: 3
• 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: SINGLE CLAMP WITH T-TYPE HANDLE
• Generic Name: ACCESSORIES, TRACTION
• Product Code: ILZ
• Date Received: 2013-12-24
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 10 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ZIMMER, INC.
• Manufacturer Address: PO BOX 708 1800 WEST CENTER STREET WARSAW IN 46581070 US 46581 0708

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-12-24