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 2020-02-19 for RETROGRADE DRL 10MM 72204046 manufactured by Smith & Nephew, Inc..
[181488649]
(b)(6). The sample is under evaluation by the manufacturing site.
Patient Sequence No: 1, Text Type: N, H10
[181488650]
It was reported that during an acl procedure, after the retrograde reaming of the tibial tunnel, the product failed to retract the protruding blade. The blade was forced to retract using other surgical instruments (probe and artery). The procedure was completed with a delay of 10-15 minutes using the same device. No patient injury or other complications were reported. Preliminary results of the investigation have concluded that the actuator wire of the drill is broken and it makes it a reportable event. 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 | 1219602-2020-00237 |
| MDR Report Key | 9728964 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-24 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-04-05 |
| Date Added to Maude | 2020-02-19 |
| 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 10MM |
| Generic Name | BIT, SURGICAL |
| Product Code | GFG |
| Date Received | 2020-02-19 |
| Returned To Mfg | 2020-01-14 |
| Catalog Number | 72204046 |
| Lot Number | 4888953 |
| 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 | 2020-02-19 |