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 2020-03-10 for MICRORAPTOR KNOTLESS SA PEEK 72205021 manufactured by Smith & Nephew, Inc..
[182775090]
It was reported that during a shoulder arthroscopy? Labrum repair procedure, the microratpor knotless could not hold the #2 ultrabraid suture tightly during the process. The anchor has successfully placed in the glenoid but the suture loosened the tension and slid out eventually from the labrum. The procedure was successfully completed with a significant delay using a back-up device in an additional bone hole. No patient injury or other complications 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
Report Number | 1219602-2020-00496 |
MDR Report Key | 9809319 |
Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
Date Received | 2020-03-10 |
Date of Report | 2020-03-09 |
Date of Event | 2020-02-12 |
Date Mfgr Received | 2020-02-13 |
Device Manufacturer Date | 2019-06-07 |
Date Added to Maude | 2020-03-10 |
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 | MICRORAPTOR KNOTLESS SA PEEK |
Generic Name | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE |
Product Code | MAI |
Date Received | 2020-03-10 |
Catalog Number | 72205021 |
Lot Number | 50810250 |
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 | 2020-03-10 |