MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-23 for RETROGRADE DRL 9.5MM 72204045 manufactured by Smith & Nephew, Inc..
[146226373]
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Patient Sequence No: 1, Text Type: N, H10
[146226374]
It was reported that during an acl reconstruction operation in or, trunav drill actuator failed proximally when the surgeon tried to actuate the cutter. This failure occurred due to buildup of bone debris around the cutter during antegrade drilling of femoral tunnel. The surgeon tried to clear the bone debris being stocked around the cutter by flossing action using trunav guidewire, but it did not work and consequently the actuator failed to deploy the cutter. A second trunav drill was used to finish retrograde drilling and the operation was completed successfully. No delay or patient injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-2019-00593 |
| MDR Report Key | 8635726 |
| Date Received | 2019-05-23 |
| Date of Report | 2019-07-02 |
| Date of Event | 2019-05-10 |
| Date Mfgr Received | 2019-07-02 |
| Device Manufacturer Date | 2019-02-25 |
| Date Added to Maude | 2019-05-23 |
| 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 | JIM GONZALES |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123585706 |
| 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 | 0 |
| Brand Name | RETROGRADE DRL 9.5MM |
| Generic Name | BIT, SURGICAL |
| Product Code | GFG |
| Date Received | 2019-05-23 |
| Returned To Mfg | 2019-05-17 |
| Catalog Number | 72204045 |
| Lot Number | 4726281 |
| 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 | 2019-05-23 |