MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1998-11-24 for ALTA MALLET 5235-2-510 manufactured by Howmedica Inc..
[116458]
Broke black handles on screwdriver. Also noticed other cracks in all black handles. This event did not occur during a surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2219689-1998-00657 |
| MDR Report Key | 199554 |
| Report Source | 07 |
| Date Received | 1998-11-24 |
| Date of Report | 1998-11-23 |
| Date Mfgr Received | 1998-07-20 |
| Date Added to Maude | 1998-12-02 |
| 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 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALTA MALLET |
| Generic Name | INSTRUMENT |
| Product Code | HXL |
| Date Received | 1998-11-24 |
| Returned To Mfg | 1998-11-14 |
| Model Number | NA |
| Catalog Number | 5235-2-510 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 193845 |
| Manufacturer | HOWMEDICA INC. |
| Manufacturer Address | 359 VETERANS BLVD. RUTHERFORD NJ 07070 US |
| Baseline Brand Name | ALTA MALLET |
| Baseline Generic Name | INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | 5235-2-510 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | A |
| Baseline Shelf Life [Months] | * |
| 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 | 1998-11-24 |