MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-06-13 for ZNN GUIDE WIRE GRIPPER N/A 00249001200 manufactured by Zimmer Biomet, Inc..
[111009488]
(b)(4). Medical product-unknown wire gripper catalog#: unk, lot#: unk. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-03165.
Patient Sequence No: 1, Text Type: N, H10
[111009489]
It was reported that during an antegrade femoral nailing procedure, two (2) wire grippers failed to grip the 3. 0 wire. There were no adverse events that occurred due to this malfunction. The surgery was completed successfully with another instrument.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-03164 |
| MDR Report Key | 7598222 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-06-13 |
| Date of Report | 2018-06-13 |
| Date of Event | 2018-05-16 |
| Date Mfgr Received | 2018-05-18 |
| Device Manufacturer Date | 2015-03-23 |
| Date Added to Maude | 2018-06-13 |
| 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 | 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 | 2018-06-13 |
| Returned To Mfg | 2018-07-11 |
| Model Number | N/A |
| Catalog Number | 00249001200 |
| Lot Number | 63017696 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-06-13 |