MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2002-05-24 for RASP HANDLE STYLE A 31-473610 manufactured by Biomet, Inc..
[247566]
Immediately following hip arthroplasty procedure in 2002, radiographs revealed a piece of coiled metal at surgical site. Pt was returned to surgery to remove fragment suspected to be a piece of the handle release mechanism.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825034-2002-00052 |
| MDR Report Key | 402039 |
| Report Source | 06,07 |
| Date Received | 2002-05-24 |
| Date of Report | 2002-05-22 |
| Date of Event | 2002-04-13 |
| Report Date | 2002-05-23 |
| Date Mfgr Received | 2002-04-25 |
| Device Manufacturer Date | 1987-01-01 |
| Date Added to Maude | 2002-07-01 |
| 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 | 3 |
| Manufacturer Contact | BETH ALBERT, AST. |
| Manufacturer Street | P.O. BOX 587 |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 5742676639 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RASP HANDLE STYLE A |
| Generic Name | INSTRUMENT |
| Product Code | GAC |
| Date Received | 2002-05-24 |
| Returned To Mfg | 2002-04-25 |
| Model Number | NA |
| Catalog Number | 31-473610 |
| Lot Number | 498080 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 391057 |
| Manufacturer | BIOMET, INC. |
| Manufacturer Address | P.O. BOX 587 WARSAW IN 465810587 US |
| Baseline Brand Name | RASP HANDLE STYLE A |
| Baseline Generic Name | INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | 31-473610 |
| Baseline ID | NA |
| Baseline Device Family | RASP HANDLE STYLE A |
| Baseline Shelf Life [Months] | NA |
| 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. Hospitalization; 2. Required No Informationntervention | 2002-05-24 |