MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-02-10 for TRINICA ATO INSTRUMENT 07.00796.001 NA manufactured by Zimmer Spine, Inc..
[18113812]
Surgeon performing 2 level, c5 to c7, trinica cervical fixation system. Opon removal of the trinica swivel ato drill guide the aligment stand broke off of the instrument, within the surgical field. The attending sales rep stated that the surgeon had very clear vision of the broken piece in the hex pocker of the locking cap on the plate. The surgeon then used suction to remove the piece from the field. After suctioning, the broken piece was no longer visible within the hex pocket of the locking cap. Review of the suction device could not confirm the removal of the broken piece. The surgeon then proceeded to wash the wound several times, and used suction, in attempts to retrieve the broker piece in case it had migrated from its original location. A second review of the suction device again could not confirm the removal of the broken piece. Post op x-rays taken did not reveal any foreign material. The broken piece is very small, approximately. 097 x. 084", and could have been overlooked during inspection of the suction instrument (s). As of the date of this report the patient has not reported any problems and is doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184052-2005-00002 |
| MDR Report Key | 575014 |
| Report Source | 07 |
| Date Received | 2005-02-10 |
| Date of Report | 2005-02-10 |
| Date of Event | 2005-01-21 |
| Date Mfgr Received | 2005-01-21 |
| Device Manufacturer Date | 2004-02-01 |
| Date Added to Maude | 2005-02-24 |
| 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 55439 |
| Manufacturer Country | US |
| Manufacturer Postal | 55439 |
| Manufacturer Phone | 9528325600 |
| Manufacturer G1 | ZIMMER SPINE |
| Manufacturer Street | 7375 BUSH LAKE ROAD |
| Manufacturer City | MINNEAPOLIS MN 55439 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55439 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRINICA ATO INSTRUMENT |
| Generic Name | TRINICA ATO SWIVEL DRILL GUIDE |
| Product Code | HXY |
| Date Received | 2005-02-10 |
| Returned To Mfg | 2005-02-01 |
| Model Number | 07.00796.001 |
| Catalog Number | NA |
| Lot Number | P040129 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 564864 |
| Manufacturer | ZIMMER SPINE, INC. |
| Manufacturer Address | * MINNEAPOLIS MN * US |
| Baseline Brand Name | TRINICA ATO INSTRUMENT |
| Baseline Generic Name | TRINICA ATO SWIVEL DRILL GUIDE |
| Baseline Model No | 07.00796.001 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-02-10 |