MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-03 for INTEGRA? JARIT? 121-140 manufactured by Integra York Pa, Inc..
[177378381]
Tungsten carbide insert came off needle driver. The piece was retrieved without issue and the instrument was sequestered for clinical engineering. The manufacturer has been notified and the device will be returned upon request. No harm came to the patient. Manufacturer response for instrument, manual, surgical, general use, integra? Jarit? (per site reporter). Awaiting response. We will return the device for failure analysis if requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9659321 |
| MDR Report Key | 9659321 |
| Date Received | 2020-02-03 |
| Date of Report | 2019-10-25 |
| Date of Event | 2019-09-19 |
| Report Date | 2019-10-25 |
| Date Reported to FDA | 2019-10-25 |
| Date Reported to Mfgr | 2020-02-03 |
| Date Added to Maude | 2020-02-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | INTEGRA? JARIT? |
| Generic Name | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
| Product Code | MDM |
| Date Received | 2020-02-03 |
| Model Number | 121-140 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK PA, INC. |
| Manufacturer Address | 589 DAVIES DR YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-03 |