Wrench

Device Code: 4505

Product Code(s): HXC

Device Type ID	4505
Device Name	Wrench
Regulation Description	Orthopedic Manual Surgical Instrument.
Regulation Medical Specialty	Orthopedic
Review Panel	Orthopedic
Premarket Review	Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2)
Submission Type	510(K) Exempt
CFR Regulation Number	888.4540 [🔎]
FDA Device Classification	Class 1 Medical Device
Product Code	HXC
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Not Third Party Eligible

Device Type ID	4505
Device	Wrench
Product Code	HXC
FDA Device Classification	Class 1 Medical Device
Regulation Description	Orthopedic Manual Surgical Instrument.
CFR Regulation Number	888.4540 [🔎]

Device Problems
Break	103
Appropriate Term/Code Not Available	48
Mechanical Problem	25
Device Operates Differently Than Expected	24
Fracture	22
Mechanical Jam	17
Bent	14
Component Missing	13
Crack	12
Disassembly	10
Output Above Specifications	8
Naturally Worn	8
Output Problem	7
Calibration Problem	6
Material Torqued	5
Material Deformation	5
Material Twisted / Bent	5
Device Inoperable	5
Difficult To Remove	4
Adverse Event Without Identified Device Or Use Problem	4
Device-Device Incompatibility	4
Loose Or Intermittent Connection	4
Material Fragmentation	3
Device Issue	2
Component Or Accessory Incompatibility	2
Failure To Disconnect	2
Insufficient Information	2
Output Below Specifications	2
Connection Problem	2
Difficult Or Delayed Separation	1
Device Operational Issue	1
Material Discolored	1
Misconnection	1
Defective Device	1
Mechanics Altered	1
Positioning Problem	1
Scratched Material	1
Dull, Blunt	1
Entrapment Of Device	1
Misassembly By Users	1
Device Contamination With Chemical Or Other Material	1
Sticking	1
Fitting Problem	1
Unintended Movement	1
Total Device Problems	383

TPLC Last Update: 2019-04-02 20:50:40