MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-04-05 for TRINICA ATO INSTRUMENT 07.00344.701 NA manufactured by Zimmer Spine, Inc..
[689494]
During surgery, the alignment stand pin broke off the instrument while the surgeon was seating the instrument on the cervical plate. According to the field rep the surgeon used a suction device to remove the broken tip from the surgical field; however, the suction device was not inspected to confirm the presence of the pin. X-rays were taken and did not reveal the broken pin in the patient. Surgery was successfully completed with the instrument. No adverse event occurred during surgery. This report is being made because there is no concrete evidence that the broken pin was successfully removed.
Patient Sequence No: 1, Text Type: D, B5
[7864766]
Testing of the device confirms instrument manufactured to correct material and heat treat specifications which agrees with the dhr. The instrument was returned but the broken pin was not.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184052-2007-00006 |
| MDR Report Key | 932833 |
| Report Source | 07 |
| Date Received | 2007-04-05 |
| Date of Report | 2007-03-12 |
| Date of Event | 2007-03-12 |
| Date Mfgr Received | 2007-03-12 |
| Device Manufacturer Date | 2006-11-01 |
| Date Added to Maude | 2007-10-26 |
| 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 | 0 |
| Manufacturer Contact | ANNETTE DOXON |
| Manufacturer Street | 7375 BUSH LAKE ROAD |
| Manufacturer City | MINNEAPOLIS MN 554392027 |
| Manufacturer Country | US |
| Manufacturer Postal | 554392027 |
| Manufacturer Phone | 9528325600 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRINICA ATO INSTRUMENT |
| Generic Name | VARIABLE ATO DRILL TUBE |
| Product Code | HXY |
| Date Received | 2007-04-05 |
| Returned To Mfg | 2007-03-13 |
| Model Number | 07.00344.701 |
| Catalog Number | NA |
| Lot Number | P061089 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 904939 |
| Manufacturer | ZIMMER SPINE, INC. |
| Manufacturer Address | * MINNEAPOLIS MN * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-04-05 |