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 2018-07-03 for ZNN GUIDE WIRE GRIPPER N/A 00249001200 manufactured by Zimmer Biomet, Inc..
[113200019]
(b)(4). Report source, foreign? Events occurred in (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[113200020]
It was reported that during a procedure, the guide wire gripper was not able to hold the guide wire. Another device was utilized to successfully complete the procedure. No adverse events have been reported as a result of the malfunction. Attempts have been made and additional information on the reported event is unavailable.
Patient Sequence No: 1, Text Type: D, B5
[134873717]
This follow-up report is being submitted to relay additional information. Complaint sample was evaluated and the reported event was not confirmed. No issue was found upon examination of the returned device. Device history record was reviewed and no discrepancies relevant to the reported event were found. Device analysis indicated that the device met specification. 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
[134873718]
No further event information available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-03519 |
| MDR Report Key | 7660845 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-07-03 |
| Date of Report | 2018-11-28 |
| Date Mfgr Received | 2018-11-26 |
| Device Manufacturer Date | 2015-07-16 |
| Date Added to Maude | 2018-07-03 |
| 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 BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZNN GUIDE WIRE GRIPPER |
| Generic Name | PASSER, WIRE |
| Product Code | HXI |
| Date Received | 2018-07-03 |
| Returned To Mfg | 2018-08-06 |
| Model Number | N/A |
| Catalog Number | 00249001200 |
| Lot Number | 63107373 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-03 |