| Device Type ID | 5580 |
| Device Name | Guide, Surgical, Instrument |
| Regulation Description | Manual Surgical Instrument For General Use. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FZX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5580 |
| Device | Guide, Surgical, Instrument |
| Product Code | FZX |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Break | 359 |
Failure To Align | 248 |
Device-Device Incompatibility | 151 |
Device Operates Differently Than Expected | 144 |
Fitting Problem | 129 |
Mechanical Jam | 93 |
Bent | 68 |
Material Fragmentation | 51 |
Material Deformation | 41 |
Fracture | 41 |
Failure To Adhere Or Bond | 34 |
Sticking | 24 |
Dull, Blunt | 20 |
Material Twisted / Bent | 20 |
Component Missing | 20 |
Use Of Device Problem | 14 |
Difficult To Remove | 13 |
Unintended Movement | 13 |
Separation Failure | 13 |
Appropriate Term/Code Not Available | 12 |
Adverse Event Without Identified Device Or Use Problem | 11 |
Difficult To Position | 11 |
Mechanical Problem | 10 |
Disassembly | 10 |
Material Integrity Problem | 9 |
Difficult To Insert | 9 |
Crack | 8 |
Detachment Of Device Or Device Component | 7 |
Naturally Worn | 7 |
Entrapment Of Device | 6 |
Positioning Problem | 6 |
Device Difficult To Maintain | 6 |
Incorrect Measurement | 5 |
Device Operational Issue | 5 |
Device Markings / Labelling Problem | 5 |
Device Packaging Compromised | 5 |
Detachment Of Device Component | 5 |
Device Handling Problem | 4 |
Material Distortion | 4 |
Compatibility Problem | 4 |
Misassembled | 4 |
Metal Shedding Debris | 3 |
Device Dislodged Or Dislocated | 3 |
Failure To Advance | 3 |
Corroded | 3 |
Difficult To Advance | 3 |
Loose Or Intermittent Connection | 3 |
Material Separation | 3 |
Peeled / Delaminated | 3 |
Device Contamination With Chemical Or Other Material | 3 |
Device Contaminated During Manufacture Or Shipping | 3 |
Physical Resistance / Sticking | 3 |
Inadequacy Of Device Shape And/or Size | 2 |
Out-Of-Box Failure | 2 |
Incomplete Or Missing Packaging | 2 |
Unsealed Device Packaging | 2 |
Device Damaged By Another Device | 2 |
Packaging Problem | 2 |
Insufficient Information | 2 |
Device Or Device Fragments Location Unknown | 2 |
Handpiece | 2 |
Deformation Due To Compressive Stress | 2 |
Delivered As Unsterile Product | 2 |
Material Frayed | 2 |
Contamination / Decontamination Problem | 2 |
Residue After Decontamination | 1 |
Shaft | 1 |
Continuous Firing | 1 |
Failure To Auto Stop | 1 |
Tip | 1 |
Material Split, Cut Or Torn | 1 |
Screw | 1 |
Pin | 1 |
Product Quality Problem | 1 |
Device Inoperable | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Misassembled During Installation | 1 |
Blocked Connection | 1 |
Difficult To Open Or Remove Packaging Material | 1 |
Defective Device | 1 |
Nonstandard Device | 1 |
Overheating Of Device | 1 |
Collapse | 1 |
Failure To Disconnect | 1 |
Malposition Of Device | 1 |
Component Or Accessory Incompatibility | 1 |
Off-Label Use | 1 |
Image Display Error / Artifact | 1 |
Accessory Incompatible | 1 |
Device Subassembly | 1 |
| Total Device Problems | 1733 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biomet, Inc. | II | May-26-2016 |
| 2 | Cook Inc. | II | Jun-14-2017 |
| 3 | Omnilife Science Inc. | II | Aug-24-2015 |
| 4 | Orthofix, Inc | II | Jun-19-2015 |
| 5 | Synthes (USA) Products LLC | II | Jul-15-2016 |
| 6 | Synthes (USA) Products LLC | II | Mar-31-2016 |
| 7 | Synthes, Inc. | II | Feb-21-2018 |
| 8 | Synthes, Inc. | II | Jun-15-2015 |
| 9 | Synthes, Inc. | II | Mar-16-2015 |
| 10 | Synthes, Inc. | II | Feb-19-2014 |
| 11 | X Spine Systems Inc | II | Aug-01-2014 |
| 12 | Zimmer Biomet, Inc. | II | Apr-20-2018 |
| 13 | Zimmer Biomet, Inc. | II | Oct-14-2016 |
| 14 | Zimmer, Inc. | II | Sep-30-2015 |