MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-11 for ZIMMER NATURAL NAIL 5.0 MM DIAMETER CORTICAL SCREW 47248402750 manufactured by Zimmer, Inc..
[60087361]
(b)(4). This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[60087362]
It is reported that the inner sealing of the packaging had adhered with the outer one and peeled with the outer one simultaneously. An alternative device was used to complete the surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2016-04125 |
| MDR Report Key | 6095866 |
| Date Received | 2016-11-11 |
| Date of Report | 2018-04-03 |
| Date Mfgr Received | 2018-04-03 |
| Device Manufacturer Date | 2016-04-22 |
| Date Added to Maude | 2016-11-11 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KATHLEEN SMITH |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal | 46580 |
| Manufacturer Phone | 8006136131 |
| Manufacturer G1 | ZIMMER, INC. |
| Manufacturer Street | 1800 WEST CENTER STREET |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46580 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ZIMMER NATURAL NAIL 5.0 MM DIAMETER CORTICAL SCREW |
| Generic Name | TRAUMA IMPLANT |
| Product Code | NDJ |
| Date Received | 2016-11-11 |
| Catalog Number | 47248402750 |
| Lot Number | 63345593 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | 1800 WEST CENTER STREET WARSAW IN 46580 US 46580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-11 |