MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-27 for SYMMETRY SHARP KERRISON 53-1661 manufactured by Symmetry Surgical Inc..
[115231582]
During the acdf, the symmetry sharp kerrison tip broke off. The surgeon ordered an x-ray. The symmetry sharp kerrison tip could not be identified in the x-ray. The symmetry sharp kerrison could not be found in the surgical field. The patient to recovery in stable condition. No untoward effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7726242 |
| MDR Report Key | 7726242 |
| Date Received | 2018-07-27 |
| Date of Report | 2018-07-02 |
| Date of Event | 2018-06-30 |
| Report Date | 2018-07-02 |
| Date Reported to FDA | 2018-07-02 |
| Date Reported to Mfgr | 2018-07-27 |
| Date Added to Maude | 2018-07-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMMETRY SHARP KERRISON |
| Generic Name | RONGEUR, MANUAL |
| Product Code | HAE |
| Date Received | 2018-07-27 |
| Catalog Number | 53-1661 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL INC. |
| Manufacturer Address | 3034 OWEN DRIVE ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-27 |