MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-09-26 for TRIGEN 71631161 manufactured by Smith & Nephew, Inc. Orthopaedic Div..
[386887]
It was reported that surgical time was extended when the screws did not align to the holes in the nail properly. The hospital staff attributed the problem to the hexdriver.
Patient Sequence No: 1, Text Type: D, B5
[7848603]
Three screws used with the hexdriver were returned. Each of these screws had been cross threaded in the field. It is possible that the cross threading of the screws is responsible for the difficulties experienced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2005-00347 |
| MDR Report Key | 637301 |
| Report Source | 07 |
| Date Received | 2005-09-26 |
| Date of Report | 2005-09-26 |
| Date of Event | 2005-09-14 |
| Date Mfgr Received | 2005-09-19 |
| Device Manufacturer Date | 2004-08-01 |
| Date Added to Maude | 2005-09-28 |
| 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 | MR. ANDY HARDISON, |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013995922 |
| Manufacturer G1 | SMITH & NEPHEW INC. ORTHOPAEDICS DIV. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIGEN |
| Generic Name | HEXDRIVER |
| Product Code | LXM |
| Date Received | 2005-09-26 |
| Model Number | NA |
| Catalog Number | 71631161 |
| Lot Number | 04HM05246 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 626846 |
| Manufacturer | SMITH & NEPHEW, INC. ORTHOPAEDIC DIV. |
| Manufacturer Address | 1450 BROOKS RD. MEMPHIS TN 38116 US |
| Baseline Brand Name | TRIGEN |
| Baseline Generic Name | HEXDRIVER |
| Baseline Model No | NA |
| Baseline Catalog No | 71631161 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-09-26 |