MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-13 for PINN CAN BONE SCREW 6.5MMX15MM 121715500 manufactured by Depuy Orthopaedics, Inc. 1818910.
[23400463]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[23400464]
During primary total hip replacement surgery, the screw driver became stuck on the screw. After five minutes trying to remove the screwdriver from the screw, it pulled the screw completely out of the drill hole and the wound. After inspection, it was noted that the screw head did not show any damage and the screwdriver was not stripped.
Patient Sequence No: 1, Text Type: D, B5
[26526930]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
Patient Sequence No: 1, Text Type: N, H10
[26749926]
The devices associated with this report were not returned. Previous investigations found this failure mode for the instrument code was reviewed under (b)(4). Preliminary risk assessment (b)(4) was conducted in april 2015 and determined this failure was related to user dissatisfaction and resulted in broadly acceptable risks. Based on the investigation, no corrective action indicated. Complaints will be monitored through post market surveillance sep 419. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2015-28010 |
| MDR Report Key | 5001098 |
| Date Received | 2015-08-13 |
| Date of Report | 2015-07-23 |
| Date of Event | 2015-07-23 |
| Date Mfgr Received | 2015-09-25 |
| Device Manufacturer Date | 2015-06-11 |
| Date Added to Maude | 2015-08-13 |
| 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 | STEVE DOWELL |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743714918 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PINN CAN BONE SCREW 6.5MMX15MM |
| Generic Name | HIP OTHER IMPLANT |
| Product Code | NDJ |
| Date Received | 2015-08-13 |
| Catalog Number | 121715500 |
| Lot Number | D14092616 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-13 |