| Device Type ID | 4498 |
| Device Name | Passer |
| 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) Restorative And Repair Devices Branch (RRDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 888.4540 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HWQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4498 |
| Device | Passer |
| Product Code | HWQ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Orthopedic Manual Surgical Instrument. |
| CFR Regulation Number | 888.4540 [🔎] |
| Device Problems | |
|---|---|
Failure To Advance | 13 |
Device Operates Differently Than Expected | 9 |
Mechanical Jam | 7 |
Material Integrity Problem | 6 |
Break | 5 |
Device Damaged Prior To Use | 4 |
Material Fragmentation | 4 |
Positioning Failure | 3 |
Fracture | 3 |
Activation, Positioning Or Separation Problem | 2 |
Device Packaging Compromised | 2 |
Detachment Of Device Component | 2 |
Insufficient Information | 2 |
Device Or Device Fragments Location Unknown | 1 |
Needle | 1 |
Difficult To Advance | 1 |
Device Handling Problem | 1 |
Unsealed Device Packaging | 1 |
Out-Of-Box Failure | 1 |
Separation Failure | 1 |
Difficult To Open Or Close | 1 |
Tip | 1 |
Appropriate Term/Code Not Available | 1 |
Loss Of Or Failure To Bond | 1 |
Difficult Or Delayed Positioning | 1 |
Bent | 1 |
Device Operational Issue | 1 |
| Total Device Problems | 76 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biomet, Inc. | II | May-26-2016 |
| 2 | Biomet, Inc. | II | Dec-23-2015 |
| 3 | Biomet, Inc. | II | Oct-09-2014 |
| 4 | Biomet, Inc. | II | Jun-16-2014 |