MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2003-04-24 for 3/8" STARTER DRILL 7650-1033 manufactured by Howmedica Osteonics Corp..
[305005]
During surgery when the tibial bone had been cut, a piece of metal was found at section.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243265-2003-00031 |
| MDR Report Key | 456710 |
| Report Source | 01,07 |
| Date Received | 2003-04-24 |
| Date of Report | 2003-03-25 |
| Date Mfgr Received | 2003-03-25 |
| Date Added to Maude | 2003-05-01 |
| 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 | 0 |
| Manufacturer Contact | NANCYE MCCAUSLAND |
| Manufacturer Street | 300 COMMERCE COURT |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3/8" STARTER DRILL |
| Generic Name | INSTRUMENT |
| Product Code | HBG |
| Date Received | 2003-04-24 |
| Model Number | NA |
| Catalog Number | 7650-1033 |
| Lot Number | SC4321 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 445703 |
| Manufacturer | HOWMEDICA OSTEONICS CORP. |
| Manufacturer Address | 59 ROUTE 17 ALLENDALE NJ 07401 US |
| Baseline Brand Name | 3/8" STARTER DRILL |
| Baseline Generic Name | SURGICAL INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | 7650-1033 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-04-24 |