MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-20 for CANNULA CLEARTRAC THREADED 7.0 X 72MM 72200905 manufactured by Smith & Nephew, Inc..
[181488685]
It was reported that during an unknown procedure, the cannula had small pieces of plastic. This device was used in the patient and the plastic piece fell off into the patient but it was retrieved from. The procedure was completed with a back up device with no delay or patient injury 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
| Report Number | 1219602-2020-00273 |
| MDR Report Key | 9734899 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-20 |
| Date of Event | 2019-12-11 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2019-06-27 |
| Date Added to Maude | 2020-02-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CANNULA CLEARTRAC THREADED 7.0 X 72MM |
| Generic Name | ACCESSORIES,ARTHROSCOPIC |
| Product Code | NBH |
| Date Received | 2020-02-20 |
| Returned To Mfg | 2020-02-13 |
| Model Number | 72200905 |
| Catalog Number | 72200905 |
| Lot Number | 905190627 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-02-20 |