MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-18 for SYMMETRY SHARP KERRISON 53-1674 manufactured by Symmetry Surgical, Llc.
[124674629]
A follow-up report will be submitted once the product is returned and evaluated.
Patient Sequence No: 1, Text Type: N, H10
[124674630]
The customer alleged that the kerrison lock closest to the distal end snapped during a laminectomy while cutting bone. There was no patient injury as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007208013-2018-00022 |
| MDR Report Key | 7982345 |
| Date Received | 2018-10-18 |
| Date of Report | 2018-10-18 |
| Date of Event | 2018-09-17 |
| Date Mfgr Received | 2018-09-21 |
| Date Added to Maude | 2018-10-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BRANDI MEATH |
| Manufacturer Street | 3034 OWEN DRIVE |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Manufacturer Phone | 6159645530 |
| Manufacturer G1 | SYMMETRY SURGICAL,LLC |
| Manufacturer Street | 3034 OWEN DRIVE |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SYMMETRY SHARP KERRISON |
| Generic Name | KERRISON RONGEUR |
| Product Code | HAE |
| Date Received | 2018-10-18 |
| Catalog Number | 53-1674 |
| Lot Number | 1545933 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL, LLC |
| Manufacturer Address | 3034 OWEN DRIVE ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-18 |