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 2019-12-02 for SET MENISCUS MENDER II DISPOSABLE 7209485 manufactured by Smith & Nephew, Inc..
[168696860]
It was reported that during an unknown procedure, the loop retriever was already disassembled between head and shaft when the package was opened. No backup device was available. No delay and no patient injuries were reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
[170780717]
One disposable meniscus mender ii kit was returned for evaluation. Visual assessment of the kit confirmed one of the suture loops shafts has been broken off where it interfaces with the handle. There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219602-2019-01514 |
| MDR Report Key | 9397827 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-02 |
| Date of Report | 2019-12-12 |
| Date of Event | 2019-11-12 |
| Date Mfgr Received | 2019-12-11 |
| Date Added to Maude | 2019-12-02 |
| 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 | HOLLY TOPPING |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123913905 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 130 FORBES BOULEVARD |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SET MENISCUS MENDER II DISPOSABLE |
| Generic Name | PASSER |
| Product Code | HWQ |
| Date Received | 2019-12-02 |
| Returned To Mfg | 2019-12-09 |
| Catalog Number | 7209485 |
| Lot Number | 2031297 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 130 FORBES BOULEVARD MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-02 |