MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-01-31 for JARIT MALLET 2LB SS 7-9/16 250404 manufactured by Integra York, Pa Inc.
[18508651]
Facility sent medwatch (b)(4) "the mallet broke while broaching right hip". Add'l info was received from the risk mgmt nurse. The procedure performed on (b)(4) 2012 was a total right hip replacement, no add'l info was provided regarding the device's breakage. An x-ray of the right hip was performed prior to closing the incision which was read as negative.
Patient Sequence No: 1, Text Type: D, B5
[18678913]
The nurse reported the device involved in the reported incident will not be returned for investigation; "it was sent out for repair". The device involved in the reported incident is not available for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2012-00014 |
| MDR Report Key | 2447083 |
| Report Source | 05,06 |
| Date Received | 2012-01-31 |
| Date of Report | 2012-01-31 |
| Date of Event | 2012-01-11 |
| Date Mfgr Received | 2012-01-30 |
| Date Added to Maude | 2012-08-10 |
| 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 | CAREN FERNANDEZ |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| 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 | 2012-01-31 |
| Catalog Number | 250404 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-31 |