MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-24 for JUGGERKNOT SOFT ANCHORS 912068 manufactured by Biomet, Inc..
[184679919]
After juggerknot was inserted, the inserting instrument was assessed and one of the two fingers on the inserter was missing, appearing to have broken off. It was discussed and determined the finger broke off inside the bone under the anchor, the surgeon stated he thought it was acceptable to leave it in the bone; attempting to retrieve it would cause more harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9871748 |
| MDR Report Key | 9871748 |
| Date Received | 2020-03-24 |
| Date of Report | 2020-02-20 |
| Date of Event | 2019-10-09 |
| Report Date | 2020-02-20 |
| Date Reported to FDA | 2020-02-20 |
| Date Reported to Mfgr | 2020-03-24 |
| Date Added to Maude | 2020-03-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JUGGERKNOT SOFT ANCHORS |
| Generic Name | FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE |
| Product Code | MBI |
| Date Received | 2020-03-24 |
| Model Number | 912068 |
| Catalog Number | 912068 |
| Lot Number | 047800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET, INC. |
| Manufacturer Address | 56 EAST BELL DR. P.O. BOX 587 WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |