MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-03-29 for SCREW BIOSURE REGENESORB 6MM X 20MM 72204391 manufactured by Smith & Nephew, Inc..
[186231835]
It was reported that during vkb surgery, the screw broke during insertion into the femoral drill channel. The broken piece was removed with tweezers. A backup device was available to complete the procedure with no delay or patient injuries. 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 | 1219602-2020-00563 |
MDR Report Key | 9896119 |
Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
Date Received | 2020-03-29 |
Date of Report | 2020-03-29 |
Date of Event | 2020-03-03 |
Date Mfgr Received | 2020-03-03 |
Device Manufacturer Date | 2019-08-28 |
Date Added to Maude | 2020-03-29 |
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 | SCREW BIOSURE REGENESORB 6MM X 20MM |
Generic Name | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE |
Product Code | MAI |
Date Received | 2020-03-29 |
Model Number | 72204391 |
Catalog Number | 72204391 |
Lot Number | 50825171 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | * |
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 | 2020-03-29 |