MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-09 for GARDNER-WELLS TONG 66-1025 manufactured by Symmetry Surgical, Inc..
[54281352]
Patient Sequence No: 1, Text Type: N, H10
[54281353]
The gardner-wells tongs were placed per manufacturer guidelines. The procedure was started and a shift in head position occurred. This alerted the staff that the tongs had actually slipped. The surgical team was able to control the head and maintain neck alignment while another set of tongs was obtained and reapplied and attached to traction. No further complications were noted. The stainless steel pinions appeared to have become dulled. This appeared to have affected the spring action in one of the pins that serves as a pressure indicator causing the tongs to slip on the skull. Manufacturer response for gardner-wells tong, symmetry surgical skull tong (per site reporter): they have no recommendations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5938789 |
| MDR Report Key | 5938789 |
| Date Received | 2016-09-09 |
| Date of Report | 2016-08-22 |
| Date of Event | 2016-07-25 |
| Report Date | 2016-08-22 |
| Date Reported to FDA | 2016-08-22 |
| Date Reported to Mfgr | 2016-08-22 |
| Date Added to Maude | 2016-09-09 |
| 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 | PATIENT |
| 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 | GARDNER-WELLS TONG |
| Generic Name | TONG, SKULL FOR TRACTION |
| Product Code | HAX |
| Date Received | 2016-09-09 |
| Model Number | 66-1025 |
| Catalog Number | 66-1025 |
| Device Availability | N |
| 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 | 2016-09-09 |