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 |