MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-05-19 for JARIT CORSS ACTION RETTACTORN 4", 1" SPREAD, BLUN * 250-111 manufactured by Vinzenz Sattler.
[390265]
The user facility reported that locking mechanism broke off at attachment screw while the device was in contact with the patient. There was no patient injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2430952-2004-00018 |
| MDR Report Key | 610156 |
| Report Source | 06 |
| Date Received | 2005-05-19 |
| Date of Report | 2005-05-19 |
| Date Facility Aware | 2005-04-21 |
| Report Date | 2005-05-19 |
| Date Reported to FDA | 2005-05-19 |
| Date Reported to Mfgr | 2005-05-19 |
| Date Added to Maude | 2005-06-06 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | YANPING WANG |
| Manufacturer Street | 311C ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362322 |
| Manufacturer G1 | J.JAMMER SURGICAL INSTRUMENTS, INC |
| Manufacturer Street | 9 SKYLINE DR |
| Manufacturer City | HAWTHORNE NY 10532 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 10532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JARIT CORSS ACTION RETTACTORN 4", 1" SPREAD, BLUN |
| Generic Name | GENERAL OPERATING INSTRUMENTS |
| Product Code | EIG |
| Date Received | 2005-05-19 |
| Returned To Mfg | 2005-04-27 |
| Model Number | * |
| Catalog Number | 250-111 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 599957 |
| Manufacturer | VINZENZ SATTLER |
| Manufacturer Address | * * GM |
| Baseline Brand Name | JARIT CORSS ACTION RETTACTORN 4", 1" SPREAD, BLUN |
| Baseline Generic Name | GENERAL OPERATING INSTRUMENTS |
| Baseline Model No | * |
| Baseline Catalog No | 250-111 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-05-19 |