MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 1996-09-16 for ALTA MALLET 5235-2-510 manufactured by Howmedica Inc..
[30079]
The handle cracked. This event did not occur during a surgical procedure, therefore, this event did not cause any adverse consequence for any pt.
Patient Sequence No: 1, Text Type: D, B5
[7760496]
Summary of evaluation: event attributed to repeated exposure to mechanical and thermal stresses. Handle design material has been modified to preclude failure. F1-14: has been completed by the mfr. The event did not occur during a surgical procedure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2219689-1996-00062 |
| MDR Report Key | 45847 |
| Report Source | 01,07 |
| Date Received | 1996-09-16 |
| Date of Report | 1996-09-13 |
| Date Mfgr Received | 1996-08-15 |
| Date Added to Maude | 1996-11-04 |
| 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 | ALTA MALLET |
| Generic Name | INSTRUMENT |
| Product Code | HXL |
| Date Received | 1996-09-16 |
| Returned To Mfg | 1996-08-15 |
| Model Number | NA |
| Catalog Number | 5235-2-510 |
| Lot Number | NA |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 46703 |
| 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 | 1996-09-16 |