MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-12-05 for OUTSIDE-IN MEDICAL REPAIR SYSTEM, MENISCUS MENDER II 7209485 manufactured by Smith & Nephew, Inc..
[169857729]
The handle of the snare within the smith & nephew meniscus mender ii (ref# 7209485) is breaking off from the stem of the snare when removing from the sterile packaging prior to use. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5091496 |
| MDR Report Key | 9426220 |
| Date Received | 2019-12-05 |
| Date of Report | 2019-12-03 |
| Date of Event | 2019-12-03 |
| Date Added to Maude | 2019-12-06 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | OUTSIDE-IN MEDICAL REPAIR SYSTEM, MENISCUS MENDER II |
| Generic Name | PASSER |
| Product Code | HWQ |
| Date Received | 2019-12-05 |
| Returned To Mfg | 2019-12-03 |
| Model Number | 7209485 |
| Catalog Number | 7209485 |
| Lot Number | 2034277 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-05 |