MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-04 for JARIT MALLET 2LB SS 7-9/16 250404 manufactured by Jarit.
[2024243]
Customer medwatch report number (b)(4) reports that 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. There was no pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[9108524]
To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2011-00014 |
| MDR Report Key | 2087443 |
| Report Source | 06 |
| Date Received | 2011-03-04 |
| Date of Report | 2011-03-03 |
| Date of Event | 2011-01-26 |
| Date Mfgr Received | 2011-02-17 |
| Date Added to Maude | 2011-05-26 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JARIT MALLET 2LB SS 7-9/16 |
| Generic Name | NA |
| Product Code | HXL |
| Date Received | 2011-03-04 |
| Catalog Number | 250404 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JARIT |
| Manufacturer Address | HAWTHORNE NY 10532 US 10532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-04 |