MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-17 for JARIT 260-504 MICROFRANCE; MILTEX; PADGETT; RUGGLES REDMOND XOMED manufactured by Jarit Gmbh/ Inter Lifesciences Corporation.
[131219747]
Surgical tech noted that a screw (measured about 5 mm in diameter and several 8 mm in length) was missing from the jarit 260-504 ronguer during a hip arthroplasty surgery. An xray was taken to confirm the screw had fallen into the posterior soft tissues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082255 |
| MDR Report Key | 8176326 |
| Date Received | 2018-12-17 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-12-12 |
| Date Added to Maude | 2018-12-18 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | JARIT 260-504 MICROFRANCE; MILTEX; PADGETT; RUGGLES REDMOND XOMED |
| Generic Name | RONGEUR |
| Product Code | HTX |
| Date Received | 2018-12-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JARIT GMBH/ INTER LIFESCIENCES CORPORATION |
| Manufacturer Address | DE US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-17 |