MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-07-28 for TRINICA ATO 07.00796.001 manufactured by Zimmer Spine, Inc..
[17146973]
When attaching the drill guide to the plate, the distal pin which seats in the plate broke off. The broken piece was retrieved. A different drill guide from the set was used to complete the case. Less than 10 minutes was added to surgery time.
Patient Sequence No: 1, Text Type: D, B5
[17315383]
Device history record reviewed. Review of device history records indicate the device was manufactured to specification. This mdr is being submitted late as this issue was identified during a retrospective review of complaint files conducted in-conjunction with implementation of revised mdr reporting criteria for zimmer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184052-2009-00044 |
| MDR Report Key | 1485826 |
| Report Source | 07 |
| Date Received | 2009-07-28 |
| Date of Report | 2007-02-28 |
| Date of Event | 2007-02-26 |
| Date Mfgr Received | 2007-02-28 |
| Device Manufacturer Date | 2005-10-14 |
| Date Added to Maude | 2010-06-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SCOTT LAPOINTE |
| Manufacturer Street | 7375 BUSH LAKE ROAD |
| Manufacturer City | MINNEAPOLIS MN 554392027 |
| Manufacturer Country | US |
| Manufacturer Postal | 554392027 |
| Manufacturer Phone | 9528325600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRINICA ATO |
| Generic Name | SWIVEL DRILL GUIDE |
| Product Code | HXY |
| Date Received | 2009-07-28 |
| Returned To Mfg | 2007-03-01 |
| Model Number | 07.00796.001 |
| Catalog Number | 07.00796.001 |
| Lot Number | P050893 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SPINE, INC. |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-07-28 |