MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-02-08 for JARIT ORTHOPEDIC 250-404 * manufactured by Jarit.
[1711223]
A mallet broke into two pieces, mallet head and handle, while hammering in knee implants. The soldering that holds the handle and mallet head together came apart. An x-ray was taken prior to closing the incision per the physician. The x-ray of knee wound was read by the physician as negative for foreign bodies. Both pieces along with a patient label were given to the charge nurse. This is a reusable instrument that the hospital resterilizes. We do not know how many times it was resterilized. The mallet was sent back to the firm for repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1994225 |
| MDR Report Key | 1994225 |
| Date Received | 2011-02-08 |
| Date of Report | 2011-02-08 |
| Date of Event | 2011-01-26 |
| Report Date | 2011-02-08 |
| Date Reported to FDA | 2011-02-08 |
| Date Added to Maude | 2011-02-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JARIT ORTHOPEDIC |
| Generic Name | MALLET |
| Product Code | HXL |
| Date Received | 2011-02-08 |
| Model Number | 250-404 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | UNKNOWN |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JARIT |
| Manufacturer Address | 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-08 |