MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2003-03-13 for EXETER RASP HANDLE 0930-9-003 manufactured by Benoist Girard.
[22168321]
It has been reported that the pin on the device sheared into two parts during a procedure. The two pieces were located by hospital personnel. The patient was x-rayed as a matter of course after procedure and nothing was visible. Another set was opened and procedure was able to be completed without consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610669-2003-00002 |
| MDR Report Key | 449983 |
| Report Source | 04,07 |
| Date Received | 2003-03-13 |
| Date of Report | 2003-01-21 |
| Date Mfgr Received | 2003-01-21 |
| Date Added to Maude | 2003-03-27 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | NANCY MCCAUSLAND |
| Manufacturer Street | 300 COMMERCE COURT |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXETER RASP HANDLE |
| Generic Name | INSTRUMENT |
| Product Code | GAC |
| Date Received | 2003-03-13 |
| Model Number | NA |
| Catalog Number | 0930-9-003 |
| Lot Number | GA651991 |
| ID Number | NA |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | I |
| Device Sequence No | 1 |
| Device Event Key | 438979 |
| Manufacturer | BENOIST GIRARD |
| Manufacturer Address | 203 BLVD DE LA GRANDE DELLE BP 8 14201 HEROUVILLE ST-CLAIR FR |
| Baseline Brand Name | EXETER RASP HANDLE |
| Baseline Generic Name | INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | 0930-9-003 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-03-13 |