| Device Type ID | 4479 |
| Device Name | Reamer |
| 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 | HTO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4479 |
| Device | Reamer |
| Product Code | HTO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Orthopedic Manual Surgical Instrument. |
| CFR Regulation Number | 888.4540 [🔎] |
| Device Problems | |
|---|---|
Dull, Blunt | 2349 |
Break | 737 |
Corroded | 495 |
Appropriate Term/Code Not Available | 318 |
Naturally Worn | 200 |
Crack | 105 |
Material Fragmentation | 103 |
Fracture | 73 |
Adverse Event Without Identified Device Or Use Problem | 72 |
Material Discolored | 71 |
Material Deformation | 55 |
Pitted | 46 |
Device-Device Incompatibility | 41 |
Failure To Cut | 37 |
Device Operates Differently Than Expected | 34 |
Insufficient Information | 26 |
Detachment Of Device Or Device Component | 25 |
Loose Or Intermittent Connection | 22 |
Mechanical Jam | 22 |
Bent | 22 |
Component Missing | 22 |
Fitting Problem | 19 |
Connection Problem | 18 |
Material Twisted / Bent | 16 |
Material Erosion | 15 |
Disassembly | 14 |
Difficult To Insert | 12 |
Scratched Material | 11 |
Mechanical Problem | 9 |
Difficult To Remove | 8 |
Failure To Adhere Or Bond | 7 |
Tip | 7 |
Device Disinfection Or Sterilization Issue | 7 |
Entrapment Of Device | 7 |
Detachment Of Device Component | 6 |
Device Reprocessing Problem | 6 |
Metal Shedding Debris | 5 |
Sticking | 5 |
Device Contamination With Chemical Or Other Material | 4 |
Component Falling | 4 |
Use Of Device Problem | 4 |
Patient-Device Incompatibility | 3 |
Device Slipped | 3 |
Packaging Problem | 3 |
Failure To Clean Adequately | 3 |
Complete Blockage | 3 |
Separation Failure | 3 |
Cut In Material | 2 |
Failure To Align | 2 |
Difficult To Advance | 2 |
Material Distortion | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Material Integrity Problem | 2 |
Device Fell | 1 |
Defective Component | 1 |
Compatibility Problem | 1 |
Guidewire | 1 |
Misconnection | 1 |
Device Stops Intermittently | 1 |
Device Inoperable | 1 |
Migration Or Expulsion Of Device | 1 |
Optical Discoloration | 1 |
Misassembled During Installation | 1 |
Loss Of Or Failure To Bond | 1 |
Overfill | 1 |
Failure To Auto Stop | 1 |
Electrical Power Problem | 1 |
Output Below Specifications | 1 |
Device Difficult To Maintain | 1 |
Shaft | 1 |
Positioning Problem | 1 |
Device Markings / Labelling Problem | 1 |
Flaked | 1 |
Monitor Failure | 1 |
Malposition Of Device | 1 |
Device Or Device Fragments Location Unknown | 1 |
Difficult To Position | 1 |
Difficult To Open Or Remove Packaging Material | 1 |
Inadequate User Interface | 1 |
Separation Problem | 1 |
Positioning Failure | 1 |
Device Handling Problem | 1 |
Hole In Material | 1 |
Unsealed Device Packaging | 1 |
Material Separation | 1 |
Device Issue | 1 |
Unintended Movement | 1 |
Physical Resistance / Sticking | 1 |
Unintended Collision | 1 |
Peeled / Delaminated | 1 |
Dent In Material | 1 |
| Total Device Problems | 5127 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Arthrex, Inc. | II | Nov-09-2018 |
| 2 | Biomet, Inc. | II | May-26-2016 |
| 3 | Biomet, Inc. | II | Oct-06-2014 |
| 4 | Cayenne Medical Inc. | II | Jul-25-2018 |
| 5 | Encore Medical, Lp | II | Aug-31-2017 |
| 6 | Synthes (USA) Products LLC | II | Mar-05-2018 |
| 7 | Synthes (USA) Products LLC | II | Nov-23-2016 |
| 8 | Synthes (USA) Products LLC | II | Nov-19-2016 |
| 9 | Synthes (USA) Products LLC | II | Jun-06-2016 |
| 10 | Synthes (USA) Products LLC | II | Jan-05-2016 |
| 11 | Synthes (USA) Products LLC | II | Aug-10-2015 |
| 12 | Synthes, Inc. | II | Jul-16-2015 |
| 13 | Trilliant Surgical Ltd. | II | Aug-24-2015 |