| Device Type ID | 4487 |
| Device Name | Impactor |
| 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 | HWA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4487 |
| Device | Impactor |
| Product Code | HWA |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Orthopedic Manual Surgical Instrument. |
| CFR Regulation Number | 888.4540 [🔎] |
| Device Problems | |
|---|---|
Break | 3115 |
Crack | 288 |
Fracture | 241 |
Appropriate Term/Code Not Available | 152 |
Naturally Worn | 68 |
Material Deformation | 40 |
Device-Device Incompatibility | 39 |
Loose Or Intermittent Connection | 36 |
Connection Problem | 36 |
Insufficient Information | 34 |
Mechanical Jam | 28 |
Disassembly | 27 |
Component Missing | 26 |
Material Fragmentation | 22 |
Difficult To Remove | 20 |
Device Operates Differently Than Expected | 17 |
Failure To Disconnect | 17 |
Detachment Of Device Or Device Component | 16 |
Dull, Blunt | 13 |
Scratched Material | 13 |
Device Contamination With Chemical Or Other Material | 13 |
Bent | 13 |
Mechanical Problem | 12 |
Adverse Event Without Identified Device Or Use Problem | 11 |
Material Twisted / Bent | 10 |
Fitting Problem | 10 |
Detachment Of Device Component | 9 |
Sticking | 7 |
Device Issue | 6 |
Device Damaged By Another Device | 6 |
Device Reprocessing Problem | 5 |
Defective Component | 3 |
Delivered As Unsterile Product | 3 |
Material Split, Cut Or Torn | 3 |
Device Dislodged Or Dislocated | 3 |
Tip | 3 |
Separation Problem | 3 |
Device Damaged Prior To Use | 3 |
Difficult To Insert | 2 |
Material Rupture | 2 |
Component Falling | 2 |
Entrapment Of Device | 2 |
Flaked | 2 |
Positioning Problem | 2 |
Defective Device | 2 |
Device Or Device Fragments Location Unknown | 2 |
Separation Failure | 2 |
Unintended Movement | 2 |
Device Difficult To Setup Or Prepare | 2 |
Degraded | 2 |
Device Difficult To Maintain | 2 |
Material Integrity Problem | 2 |
Failure To Adhere Or Bond | 2 |
Corroded | 2 |
Device Operational Issue | 2 |
Problem With Sterilization | 1 |
Burst Container Or Vessel | 1 |
Migration Or Expulsion Of Device | 1 |
Pitted | 1 |
Material Discolored | 1 |
Misconnection | 1 |
Device Inoperable | 1 |
Device Fell | 1 |
Compatibility Problem | 1 |
Explosion | 1 |
Contamination / Decontamination Problem | 1 |
Screw | 1 |
Particulates | 1 |
Retraction Problem | 1 |
Use Of Device Problem | 1 |
Structural Problem | 1 |
Delamination | 1 |
No Apparent Adverse Event | 1 |
Circuit Breaker | 1 |
Physical Resistance / Sticking | 1 |
Failure To Clean Adequately | 1 |
Peeled / Delaminated | 1 |
Loss Of Osseointegration | 1 |
Dent In Material | 1 |
Material Protrusion / Extrusion | 1 |
Locking Mechanism | 1 |
Blocked Connection | 1 |
Device Slipped | 1 |
Failure To Align | 1 |
Failure To Discharge | 1 |
Fluid Leak | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Imprecision | 1 |
Disconnection | 1 |
| Total Device Problems | 4439 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Encore Medical, Lp | II | Mar-08-2017 |
| 2 | Encore Medical, Lp | II | Oct-30-2015 |
| 3 | Greatbatch Medical | I | Nov-29-2016 |
| 4 | Greatbatch Medical | I | Mar-06-2014 |
| 5 | Stryker Howmedica Osteonics Corp. | II | Oct-07-2016 |
| 6 | Zimmer Biomet, Inc. | II | Feb-14-2018 |
| 7 | Zimmer, Inc. | II | Nov-24-2014 |