MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-06-03 for SYMMETRY RHOTON MICRO CUP FORCEPS 53-4008 manufactured by Symmetry Surgical Inc..
[5903058]
Micro pituitary broke intra-operatively while doctor was using it on a cervical disc. The item was removed from the sterile filed and given to materials coordinator. The wound was checked with microscope, all pieces accounted for. X-ray done and read by radiology. X-ray negative for instruments or from broken pituitary. Doctor aware of the x-ray results. No harm to the pt. Original intended procedure: c5-6, c6-7 anterior cervical diskectomies, allograft fusions and the anterior cervical plating using a medtronic venture plate. Device failed (e. G. Broke, couldn't get it to work or stopped working).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007208013-2015-00007 |
| MDR Report Key | 4828289 |
| Report Source | 06 |
| Date Received | 2015-06-03 |
| Date of Report | 2015-06-01 |
| Date of Event | 2014-10-09 |
| Date Facility Aware | 2015-03-19 |
| Report Date | 2015-06-01 |
| Date Reported to FDA | 2015-03-19 |
| Date Reported to Mfgr | 2015-04-28 |
| Date Mfgr Received | 2015-04-28 |
| Date Added to Maude | 2015-06-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRIS SMITH |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Manufacturer Phone | 8002513000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMMETRY RHOTON MICRO CUP FORCEPS |
| Generic Name | MICRO CUP FORCEPS |
| Product Code | GZX |
| Date Received | 2015-06-03 |
| Model Number | 53-4008 |
| Catalog Number | 53-4008 |
| Lot Number | UNK |
| ID Number | 00887482023495 |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-06-03 |