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 2020-03-12 for RETROGRADE DRL 8MM 72204042 manufactured by Smith & Nephew, Inc..
[183112847]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[183112848]
It was reported that during surgery, when using the acufex trunav retrograde drill and trying to pull the cutting blade back into the shaft, it did not move. So, surgeon had to drill all the way through the tibia and had to use a medium xtendobutton round instead of the surgeon's normal technique (all inside drilling). It is unknown if there was a delay in the procedure. Procedure was changed, but it was completed with the same device. 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
Report Number | 1219602-2020-00511 |
MDR Report Key | 9823487 |
Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
Date Received | 2020-03-12 |
Date of Report | 2020-03-12 |
Date of Event | 2020-02-17 |
Date Mfgr Received | 2020-02-17 |
Device Manufacturer Date | 2019-04-29 |
Date Added to Maude | 2020-03-12 |
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 | RETROGRADE DRL 8MM |
Generic Name | BIT, SURGICAL |
Product Code | GFG |
Date Received | 2020-03-12 |
Catalog Number | 72204042 |
Lot Number | 4821694 |
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 | 2020-03-12 |