MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-10-28 for INTERTAN 71674076 manufactured by Smith-nephew Inc..
[8833362]
From the analyses conducted during this investigation, it was shown that the t-handle fractured in the 'ear' of the handle in the clamping jaw, likely from static bending or torsional overload. An overload fracture can occur if the mechanical loads applied to the device exceed the strength of the material. No material or manufacturing deviations were found during this investigation.
Patient Sequence No: 1, Text Type: N, H10
[18180965]
It was reported that surgery time was extended due to a broken t-handle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2010-00306 |
| MDR Report Key | 1884924 |
| Report Source | 07 |
| Date Received | 2010-10-28 |
| Date of Report | 2011-03-10 |
| Date of Event | 2010-08-25 |
| Date Mfgr Received | 2010-10-13 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2010-10-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHADWICK BROWN |
| Manufacturer Street | 1450 BROOKS RD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013995182 |
| Manufacturer G1 | SMITH-NEPHEW INC. |
| Manufacturer Street | 1450 BROOKS RD |
| 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 | INTERTAN |
| Generic Name | T-HANDLE |
| Product Code | LYT |
| Date Received | 2010-10-28 |
| Catalog Number | 71674076 |
| Lot Number | 09ACT0010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH-NEPHEW INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2010-10-28 |