MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-10-08 for HOEN 65-1102 manufactured by Symmetry Surgical Inc..
[28616639]
Symmetry did not receive the broken device back from the hospital. Device failure was determined to be misuse of the product. Instrument specialist on site indicated: device is intended to separate the dura mater that coats the brain and the spinal cord, device should not be struck.
Patient Sequence No: 1, Text Type: N, H10
[28616640]
During a posterior lumbar discectomy the tip of the hoen dural separator broke off inside the patient when struck with a mallet by the surgeon. A c-arm x-ray was brought in to locate the broken tip that was in the patient. The broken piece was recovered without harm to the patient. The device was disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007208013-2015-00026 |
| MDR Report Key | 5147864 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-10-08 |
| Date of Report | 2015-10-07 |
| Date of Event | 2015-08-13 |
| Date Facility Aware | 2015-08-13 |
| Report Date | 2015-08-21 |
| Date Reported to FDA | 2015-08-21 |
| Date Reported to Mfgr | 2015-08-25 |
| Date Mfgr Received | 2015-08-25 |
| Device Manufacturer Date | 2010-04-01 |
| Date Added to Maude | 2015-10-14 |
| 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 | MS VICTORIA ROGERS |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Manufacturer Phone | 8002513000 |
| Manufacturer G1 | SYMMETRY SURGICAL INC. |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 370130000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 370130000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOEN |
| Generic Name | DURAL SEPARATOR |
| Product Code | GAF |
| Date Received | 2015-10-08 |
| Model Number | 65-1102 |
| Catalog Number | 65-1102 |
| Device Availability | * |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL INC. |
| Manufacturer Address | 3034 OWEN DR ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-08 |