MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-09 for TORQUE-SHANK, T7X80 CANNULATED, AO CONNECTOR 54098-80 manufactured by I.t.s. Gmbh.
[132810585]
The device history record (dhr) of the last three shipments of the screwdriver shank 54098-80 and the resp. Screws that were send to general care were inspected and showed no deviations. The quality forms met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing that would contribute to this complaint condition. A review of the raw material device history record revealed no deviation. The material was determined to be conforming and was used as is per product development approval. We have tested the shank with multiple hcs screws from our stock and the shank engaged smoothly in the torque-profile. No deviation resp. Non-conformance detected.
Patient Sequence No: 1, Text Type: N, H10
[132810586]
It was reported that a headless compression screw was mismatching with the torque shank. The incident didn't happen in surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004369035-2016-00007 |
| MDR Report Key | 8230403 |
| Date Received | 2019-01-09 |
| Date of Report | 2019-01-09 |
| Date Mfgr Received | 2016-05-11 |
| Date Added to Maude | 2019-01-09 |
| 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. FLORIAN GRILL |
| Manufacturer Street | AUTAL 28 |
| Manufacturer City | LASSNITZH[?]HE, STYRIA 8301 |
| Manufacturer Country | AU |
| Manufacturer Postal | 8301 |
| Manufacturer G1 | I.T.S. GMBH |
| Manufacturer Street | AUTAL 28 |
| Manufacturer City | LASSNITZH[?]HE, STYRIA 8301 |
| Manufacturer Country | AU |
| Manufacturer Postal Code | 8301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TORQUE-SHANK, T7X80 CANNULATED, AO CONNECTOR |
| Generic Name | TORQUE-SHANK, T7X80 CANNULATED, AO CONNECTOR |
| Product Code | LRZ |
| Date Received | 2019-01-09 |
| Model Number | 54098-80 |
| Catalog Number | 54098-80 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | I.T.S. GMBH |
| Manufacturer Address | AUTAL 28 LASSNITZH[?]HE, STYRIA 8301 AU 8301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-09 |