MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 1997-05-12 for PCA INTERCONDYLAR DRILL GUIDE 6838-7-676 manufactured by Howmedica, Inc..
[61571]
One of the spikes broke off the drill guide. There was no adverse consequence for the pt or delay in surgery or anesthesia time.
Patient Sequence No: 1, Text Type: D, B5
[7826436]
Summary of evaluation: the results of the evaluation suggest that this event was the result of a less than optimum design of the fixation pins. Corrective action has long since been implemented to preclude this complaint mode. No similar events have been reported with the latest revision device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2219689-1997-00240 |
| MDR Report Key | 91229 |
| Report Source | 01,07 |
| Date Received | 1997-05-12 |
| Date of Report | 1997-05-09 |
| Report Date | 1997-05-09 |
| Date Mfgr Received | 1997-04-04 |
| Date Added to Maude | 1997-05-19 |
| 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 INTERCONDYLAR DRILL GUIDE |
| Generic Name | INSTRUMENT |
| Product Code | HXY |
| Date Received | 1997-05-12 |
| Model Number | NA |
| Catalog Number | 6838-7-676 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 90130 |
| Manufacturer | HOWMEDICA, INC. |
| Manufacturer Address | 359 VETERANS BLVD. RUTHERFORD NJ 070702584 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 | 1. Other | 1997-05-12 |