MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-05-04 for ZIMMER NATURAL NAIL SYSTEM GUIDE WIRE GRIPPER N/A 00249001200 manufactured by Zimmer, Inc..
[74399504]
(b)(4). Customer has indicated that the device is in the process of being returned to zimmer biomet for evaluation. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[74399505]
It was reported that the guide wire gripper does not grip. There was no patient involvement, as this was discovered during sterilization.
Patient Sequence No: 1, Text Type: D, B5
[77953897]
This follow-up report is being submitted to relay additional information. Upon reassessment of the reported event, it was determined that this complaint is a duplicate complaint. It is also noted to be a not reportable event, as this event was found in sterilization and had no patient interaction or impact. The initial reported was forwarded in error and should be voided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001822565-2017-03027 |
| MDR Report Key | 6543844 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-04 |
| Date of Report | 2017-05-26 |
| Date of Event | 2017-01-17 |
| Date Mfgr Received | 2017-05-05 |
| Device Manufacturer Date | 2014-01-30 |
| Date Added to Maude | 2017-05-04 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| 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 | 3 |
| Brand Name | ZIMMER NATURAL NAIL SYSTEM GUIDE WIRE GRIPPER |
| Generic Name | PASSER, WIRE |
| Product Code | HXI |
| Date Received | 2017-05-04 |
| Model Number | N/A |
| Catalog Number | 00249001200 |
| Lot Number | 62597689 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-05-04 |