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 2018-11-13 for GUIDE WIRE GRIPPER N/A 00249001200 manufactured by Zimmer Biomet, Inc..
[127372003]
(b)(4). (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. Expected, not yet received.
Patient Sequence No: 1, Text Type: N, H10
[127372004]
It was reported during a tibial nail procedure, the guide wire gripper instrument was unable to grip the guide wire. The surgeon used another instrument to complete the procedure. No adverse events were reported.
Patient Sequence No: 1, Text Type: D, B5
[131707570]
Complaint sample was evaluated and the reported event was not confirmed. The device exhibited wear marks around the 2. 4 and 3. 0mm holes which could lead to the reported event and would be normal, expected instrument wear. Root cause could not be determined. 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
[131707571]
No additional information received.
Patient Sequence No: 1, Text Type: D, B5
[131707776]
Patient Sequence No: 1, Text Type: N, H10
[131707777]
No additional information received.
Patient Sequence No: 1, Text Type: D, B5
[131711285]
Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[131711286]
No additional information received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-06379 |
| MDR Report Key | 8067744 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-13 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-10-17 |
| Date Mfgr Received | 2018-12-21 |
| Device Manufacturer Date | 2015-04-21 |
| Date Added to Maude | 2018-11-13 |
| 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 | GUIDE WIRE GRIPPER |
| Generic Name | PASSER, WIRE |
| Product Code | HXI |
| Date Received | 2018-11-13 |
| Returned To Mfg | 2018-12-05 |
| Model Number | N/A |
| Catalog Number | 00249001200 |
| Lot Number | 63017696 |
| 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 | 2018-11-13 |