MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-04-25 for SLOTTED MALLET 14-442053 manufactured by Ebi.
[832941]
It was reported that the mallet broke while driving a nail down during an intertrochanteric fixation. The medullary canal was adequately reamed prior to nail insertion. An additional mallet was available and was used to complete the case. Pt status is good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242816-2008-00058 |
| MDR Report Key | 1034509 |
| Report Source | 05 |
| Date Received | 2008-04-25 |
| Date of Report | 2008-04-23 |
| Date of Event | 2008-04-10 |
| Date Mfgr Received | 2008-04-23 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2008-09-18 |
| 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 | ART KAUFMAN, SR. DIRECTOR |
| Manufacturer Street | 100 INTERPACE PKWY. |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9732999300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SLOTTED MALLET |
| Product Code | HXL |
| Date Received | 2008-04-25 |
| Returned To Mfg | 2008-04-21 |
| Catalog Number | 14-442053 |
| Lot Number | 502398 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1033630 |
| Manufacturer | EBI |
| Manufacturer Address | PARSIPPANY NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-25 |