MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-17 for ENNOVATE TORQUE WRENCH HANDLE 10NM SZ228R manufactured by Aesculap Ag.
[183942964]
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[183942965]
It was reported that there was an issue with product ennovate torque wrench handle. Following information was reported: the screw could not be implanted. The incident occurred during spine surgery l5,s1. After rod insertion the caudal screws were blocked and fixed with setscrew. It was not possible to tighten the set screw on the left side with a torque wrench. Decision was made to place a new screw with the diameter 7. 5mm instead of 6. 5mm; but it was also not possible. Changed to t-handle and the set screw could be tightened. Surgery extension time was about 25 minutes. An additional medical intervention was necessary. The surgeon needs to use a larger screw. Additional information was not provided nor available the adverse event is filed under aag reference (b)(4). Associated medwatch-reports: 9610612-2020-00077 ((b)(4) + sy635ts).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2020-00078 |
| MDR Report Key | 9841838 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2017-09-12 |
| Date Added to Maude | 2020-03-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS KERSTIN ROTHWEILER |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78501 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENNOVATE TORQUE WRENCH HANDLE 10NM |
| Generic Name | INSTRUMENTS POSTERIOR STABILISATION |
| Product Code | HXC |
| Date Received | 2020-03-17 |
| Returned To Mfg | 2020-03-06 |
| Model Number | SZ228R |
| Catalog Number | SZ228R |
| Lot Number | 52339213 |
| Device Expiration Date | 2017-09-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-17 |