MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-22 for SYMMETRY KERRISON RONGEUR 53-1512 manufactured by Symmetry Surgical Inc.
[109118207]
During a spinal orthopedic procedure, the surgeon attempted to use a 2mm kerrison rongeur for cleaning out and shaping bone cavity when the instrument failed. The spring on the finger grip side of the rongeur broke at the point where the spring was attached to the finger grip side handle. The spring separated at the drilled section of the spring causing the rongeur spring to separate and making the instrument inoperable. The kerrison rongeur was replaced and the surgery continued without event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007208013-2018-00006 |
| MDR Report Key | 7535503 |
| Date Received | 2018-05-22 |
| Date of Report | 2018-06-29 |
| Date of Event | 2018-04-01 |
| Date Mfgr Received | 2018-05-01 |
| Date Added to Maude | 2018-05-22 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. VICTORIA ROGERS |
| Manufacturer Street | 3034 OWEN DRIVE |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Manufacturer Phone | 8002513000 |
| Manufacturer G1 | SYMMETRY SURGICAL INC |
| 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 KERRISON RONGEUR |
| Generic Name | KERRISON RONGEUR |
| Product Code | HAE |
| Date Received | 2018-05-22 |
| Model Number | 53-1512 |
| Catalog Number | 53-1512 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-05-22 |