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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 3334 3334

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 13824 13824
Naturally Worn 1989 1989
Break 1632 1632
Dull, Blunt 1384 1384
Corroded 1262 1262
Material Twisted/Bent 699 699
Device-Device Incompatibility 681 681
Adverse Event Without Identified Device or Use Problem 481 481
No Apparent Adverse Event 458 458
Entrapment of Device 327 327
Material Deformation 321 321
Illegible Information 297 297
Contamination /Decontamination Problem 168 168
Crack 110 110
Fracture 71 71
Scratched Material 67 67
Detachment of Device or Device Component 60 60
Mechanical Jam 56 56
Device Contamination with Chemical or Other Material 46 46
Degraded 44 44
Material Discolored 40 40
Device Contaminated During Manufacture or Shipping 33 33
Material Integrity Problem 31 31
Loose or Intermittent Connection 24 24
Physical Resistance/Sticking 22 22
Component Missing 21 21
Unintended Movement 21 21
Improper or Incorrect Procedure or Method 17 17
Difficult to Insert 13 13
Appropriate Term/Code Not Available 12 12
Use of Device Problem 8 8
Peeled/Delaminated 8 8
Structural Problem 7 7
Product Quality Problem 7 7
Material Fragmentation 6 6
Difficult to Open or Close 6 6
Difficult to Remove 5 5
Device Slipped 5 5
Off-Label Use 4 4
Failure to Advance 4 4
Device Damaged Prior to Use 4 4
Mechanical Problem 4 4
Connection Problem 4 4
Failure to Clean Adequately 4 4
Defective Device 3 3
Insufficient Information 3 3
Positioning Failure 3 3
Loss of or Failure to Bond 2 2
Material Disintegration 2 2
Pitted 2 2
Delivered as Unsterile Product 2 2
Defective Component 2 2
Fitting Problem 2 2
Problem with Sterilization 2 2
Material Separation 2 2
Inadequacy of Device Shape and/or Size 2 2
Noise, Audible 2 2
Material Split, Cut or Torn 2 2
Positioning Problem 2 2
Difficult to Open or Remove Packaging Material 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Compatibility Problem 1 1
Device Dislodged or Dislocated 1 1
Device Tipped Over 1 1
Patient-Device Incompatibility 1 1
Battery Problem 1 1
Communication or Transmission Problem 1 1
Packaging Problem 1 1
Measurement System Incompatibility 1 1
Device Handling Problem 1 1
Device Difficult to Maintain 1 1
Particulates 1 1
Misassembled 1 1
Difficult or Delayed Positioning 1 1
Incomplete or Inadequate Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15726 15726
No Consequences Or Impact To Patient 2614 2614
Insufficient Information 918 918
No Code Available 405 405
Foreign Body In Patient 337 337
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
Limb Fracture 18 18
Unspecified Tissue Injury 17 17
Pain 13 13
Non-union Bone Fracture 9 9
Blood Loss 6 6
Failure of Implant 6 6
Septic Shock 5 5
Device Embedded In Tissue or Plaque 5 5
No Information 4 4
Shock 4 4
Loss of Range of Motion 4 4
Hemorrhage/Bleeding 4 4
Low Blood Pressure/ Hypotension 3 3
Discomfort 3 3
Post Operative Wound Infection 3 3
Tissue Damage 2 2
Hematoma 2 2
Fall 2 2
Foreign Body Reaction 1 1
Ossification 1 1
Pulmonary Embolism 1 1
Anemia 1 1
Bradycardia 1 1
Burn(s) 1 1
Cyst(s) 1 1
Embolism 1 1
Respiratory Distress 1 1
Laceration(s) 1 1
Nerve Damage 1 1
Neurological Deficit/Dysfunction 1 1
Perforation of Vessels 1 1
Physical Entrapment 1 1
Skin Tears 1 1
Hip Fracture 1 1
Deformity/ Disfigurement 1 1
Patient Problem/Medical Problem 1 1
Hyperextension 1 1
Paresthesia 1 1
Unspecified Nervous System Problem 1 1
Swelling/ Edema 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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