MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1996-12-09 for ARTISAN BONE PLUG 6215-5-001 manufactured by Howmedica, Inc..
[39007]
It was noticed that the bone plug did not contain threads. There was no pt involvement at the time this event was noticed; therefore, there was no adverse effect to any pt.
Patient Sequence No: 1, Text Type: D, B5
[15394039]
A visual inspection of the returned bone plug revealed no significant discrepancies. A functional check was performed with both the thread gage and an actual plug inserter. The results of the functional check verified the field complaint. The plug accepted the no-go gage, and the plug would not thread onto the inserter tool. A review of the product history revealed no other similar complaints with this lot code. Corrective action was taken to prevent this condition from recurring.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2219689-1996-00304 |
| MDR Report Key | 55440 |
| Report Source | 07 |
| Date Received | 1996-12-09 |
| Date of Report | 1996-12-06 |
| Report Date | 1996-12-06 |
| Date Mfgr Received | 1996-11-07 |
| Device Manufacturer Date | 1996-04-01 |
| Date Added to Maude | 1996-12-16 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTISAN BONE PLUG |
| Generic Name | BONE PLUG |
| Product Code | MBS |
| Date Received | 1996-12-09 |
| Returned To Mfg | 1996-11-07 |
| Model Number | NA |
| Catalog Number | 6215-5-001 |
| Lot Number | UNBWA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 55976 |
| Manufacturer | HOWMEDICA, INC. |
| Manufacturer Address | 359 VETERANS BLVD. RUTHERFORD NJ 07070 US |
| Baseline Brand Name | ARTISAN BONE PLUG |
| Baseline Generic Name | BONE PLUG |
| Baseline Model No | NA |
| Baseline Catalog No | 6215-5-001 |
| Baseline ID | * |
| Baseline Device Family | BONE PLUG |
| Baseline Shelf Life Contained | N |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K951860 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-12-09 |