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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reamer
Product CodeHTO
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2019 1955 1955
2020 1531 1531
2021 4802 4802
2022 3909 3909
2023 4405 4405
2024 1618 1618

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 12581 12581
Naturally Worn 1980 1980
Break 1566 1566
Dull, Blunt 1384 1384
Corroded 1219 1219
Material Twisted/Bent 699 699
Device-Device Incompatibility 654 654
Adverse Event Without Identified Device or Use Problem 472 472
Material Deformation 307 307
Entrapment of Device 304 304
Illegible Information 287 287
No Apparent Adverse Event 155 155
Crack 105 105
Contamination /Decontamination Problem 104 104
Scratched Material 63 63
Fracture 61 61
Detachment of Device or Device Component 56 56
Mechanical Jam 54 54
Device Contamination with Chemical or Other Material 46 46
Degraded 43 43
Material Discolored 40 40
Device Contaminated During Manufacture or Shipping 32 32
Material Integrity Problem 31 31
Loose or Intermittent Connection 24 24
Physical Resistance/Sticking 22 22
Unintended Movement 21 21
Component Missing 21 21
Improper or Incorrect Procedure or Method 14 14
Difficult to Insert 13 13
Appropriate Term/Code Not Available 12 12
Use of Device Problem 8 8
Peeled/Delaminated 8 8
Product Quality Problem 7 7
Difficult to Open or Close 6 6
Material Fragmentation 6 6
Device Slipped 5 5
Structural Problem 5 5
Connection Problem 4 4
Failure to Advance 4 4
Difficult to Remove 4 4
Mechanical Problem 4 4
Device Damaged Prior to Use 4 4
Off-Label Use 4 4
Failure to Clean Adequately 4 4
Positioning Failure 3 3
Insufficient Information 3 3
Noise, Audible 2 2
Defective Device 2 2
Difficult to Open or Remove Packaging Material 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Positioning Problem 2 2
Material Separation 2 2
Fitting Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Pitted 2 2
Problem with Sterilization 2 2
Defective Component 2 2
Delivered as Unsterile Product 2 2
Material Split, Cut or Torn 2 2
Loss of or Failure to Bond 2 2
Device Tipped Over 1 1
Device Dislodged or Dislocated 1 1
Particulates 1 1
Device Difficult to Maintain 1 1
Difficult or Delayed Positioning 1 1
Misassembled 1 1
Compatibility Problem 1 1
Battery Problem 1 1
Measurement System Incompatibility 1 1
Patient-Device Incompatibility 1 1
Communication or Transmission Problem 1 1
Incomplete or Inadequate Connection 1 1
Device Handling Problem 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14298 14298
No Consequences Or Impact To Patient 2614 2614
Insufficient Information 632 632
No Code Available 405 405
Foreign Body In Patient 313 313
Not Applicable 151 151
No Patient Involvement 81 81
Bone Fracture(s) 48 48
Injury 31 31
No Known Impact Or Consequence To Patient 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Unspecified Infection 20 20
Unspecified Tissue Injury 16 16
Pain 13 13
Limb Fracture 10 10
Non-union Bone Fracture 9 9
Blood Loss 6 6
Failure of Implant 6 6
Septic Shock 5 5
Loss of Range of Motion 4 4
Shock 4 4
Device Embedded In Tissue or Plaque 4 4
Hemorrhage/Bleeding 4 4
No Information 4 4
Low Blood Pressure/ Hypotension 3 3
Discomfort 3 3
Post Operative Wound Infection 3 3
Tissue Damage 2 2
Fall 2 2
Hematoma 2 2
Neurological Deficit/Dysfunction 1 1
Skin Tears 1 1
Swelling/ Edema 1 1
Patient Problem/Medical Problem 1 1
Unspecified Nervous System Problem 1 1
Embolism 1 1
Nerve Damage 1 1
Hyperextension 1 1
Bradycardia 1 1
Foreign Body Reaction 1 1
Physical Entrapment 1 1
Burn(s) 1 1
Cyst(s) 1 1
Pulmonary Embolism 1 1
Laceration(s) 1 1
Ossification 1 1
Respiratory Distress 1 1
Anemia 1 1
Perforation of Vessels 1 1
Paresthesia 1 1
Deformity/ Disfigurement 1 1
Hip Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Synthes (USA) Products LLC II Mar-01-2024
2 Synthes (USA) Products LLC II Dec-15-2020
3 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Mar-20-2020
4 Zimmer, Inc. II Feb-06-2023
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