MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-08-30 for JUGGERLOC BONE-TO-BONE STAINLESS STEEL ROUND BUTTON WITH SOLID DRILLS KIT N/A 110007337 manufactured by Zimmer Biomet, Inc..
[118868584]
(b)(4). The investigation is in process. 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: 0001825034 - 2018 - 08571.
Patient Sequence No: 1, Text Type: N, H10
[118868585]
It was reported that during am ankle syndesmosis repair procedure, upon tightening the button down to the plate, the juggerloc implant pulled out of the bone. The patient's bone was re-drilled and second kit was attempted to be implanted, but this anchor also pulled out of the bone. Surgery was successfully completed with competitor's screw. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-08570 |
| MDR Report Key | 7836138 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-30 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-07-30 |
| Date Mfgr Received | 2018-08-02 |
| Device Manufacturer Date | 2018-03-21 |
| Date Added to Maude | 2018-08-30 |
| 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 | JUGGERLOC BONE-TO-BONE STAINLESS STEEL ROUND BUTTON WITH SOLID DRILLS KIT |
| Generic Name | WASHER, BOLT |
| Product Code | HTN |
| Date Received | 2018-08-30 |
| Model Number | N/A |
| Catalog Number | 110007337 |
| Lot Number | 294370 |
| 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 BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 110007337 | 1. Required No Informationntervention | 2018-08-30 |