MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-27 for LOCKING SCREWDRIVER BODY 2307-92-003 230792003 manufactured by Depuy France Sas - 3003895575.
[185429590]
Product complaint #: (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[185429593]
It was report that the screw driver broke. No surgical delay reported.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1818910-2020-09529 |
MDR Report Key | 9891605 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2020-03-27 |
Date of Report | 2020-03-11 |
Date of Event | 2020-03-11 |
Date Mfgr Received | 2020-03-11 |
Device Manufacturer Date | 2013-05-16 |
Date Added to Maude | 2020-03-27 |
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 | 3 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | KARA DITTY-BOVARD |
Manufacturer Street | 700 ORTHOPAEDIC DR. |
Manufacturer City | WARSAW IN 465810988 |
Manufacturer Country | US |
Manufacturer Postal | 465810988 |
Manufacturer Phone | 6107428552 |
Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
Manufacturer Street | 700 ORTHOPAEDIC DR. |
Manufacturer City | WARSAW IN 465810988 |
Manufacturer Country | US |
Manufacturer Postal Code | 465810988 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | LOCKING SCREWDRIVER BODY |
Generic Name | EXTREMITY INSTRUMENTS : SCREWDRIVERS |
Product Code | HXX |
Date Received | 2020-03-27 |
Model Number | 2307-92-003 |
Catalog Number | 230792003 |
Lot Number | 5209164 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | DEPUY FRANCE SAS - 3003895575 |
Manufacturer Address | 7 ALLEE IRENE JOLIOT-CURIE B.P. 256 SAINT PRIEST CEDEX 69801 FR 69801 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-27 |