MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1996-09-05 for PCA UNIVERSAL INTERCONDYLAR DRILL GUIDE 6838-7-676 manufactured by Howmedica, Inc.
[21861]
While inspecting the instrument, it was noticed, the pegs were bent and starting to break off. This event did not occur during a surgical procedure and was noted this occurred over time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2219689-1996-00027 |
| MDR Report Key | 39949 |
| Report Source | 07 |
| Date Received | 1996-09-05 |
| Date of Report | 1996-08-30 |
| Date Mfgr Received | 1996-07-31 |
| Date Added to Maude | 1996-10-01 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PCA UNIVERSAL INTERCONDYLAR DRILL GUIDE |
| Generic Name | INSTRUMENT |
| Product Code | HXY |
| Date Received | 1996-09-05 |
| Returned To Mfg | 1996-07-31 |
| Model Number | NA |
| Catalog Number | 6838-7-676 |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 41075 |
| Manufacturer | HOWMEDICA, INC |
| Manufacturer Address | 824 SO 75TH STREET OMAHA NE 68114 US |
| Baseline Brand Name | PCA UNIVERSAL INTERCONDYLAR DRILL GUIDE |
| Baseline Generic Name | INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | 6838-7-676 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | N |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-09-05 |