MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2011-07-06 for NEXGEN PATELLAR DRILL GUIDE 00597900132 manufactured by Zimmer, Inc..
[20912386]
It is reported that a spike has fractured off the patella guide.
Patient Sequence No: 1, Text Type: D, B5
[21235326]
Eval summary: the device shows strike marks on the top and sides of the device and may indicate off-axis impaction. However, conclusive info is not available to make this determination. A definitive root cause cannot be determined with the info provided. As returned the drill guide exhibits a fractured pin on the 32 mm side of the device. The fractured pin was not returned for eval. The device meets specs as measured. Additionally the device history records were reviewed; indicating the device was mfg to applicable specs.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2011-01597 |
| MDR Report Key | 2177991 |
| Report Source | 05,08 |
| Date Received | 2011-07-06 |
| Date of Report | 2011-06-06 |
| Date of Event | 2011-05-31 |
| Date Mfgr Received | 2011-06-06 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2011-09-01 |
| 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 | KEVIN ESCAPULE |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 8006136131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEXGEN PATELLAR DRILL GUIDE |
| Generic Name | KNEE INSTRUMENT |
| Product Code | LXI |
| Date Received | 2011-07-06 |
| Returned To Mfg | 2011-06-06 |
| Catalog Number | 00597900132 |
| Lot Number | 60244250 |
| 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, INC. |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 46581070 US 46581 0708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-06 |