MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-26 for S4 SET SCREW NEW VERSION SW790T manufactured by Aesculap Ag.
[181372042]
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report when it becomes available.
Patient Sequence No: 1, Text Type: N, H10
[181372043]
It was reported that there was an issue with s4 set screw. According to the customer report: unable to tighten setscrew using a screwdriver fw732r. While final tightening the setscrew, the surgeon tightened the screwdriver, however the driver kept rotating even after 10n/m was obtained. At the torque value of 10n/m, the torque should have come off in order to avoid excessive torque, however, the screwdriver kept on rotating and the setscrew and the polyaxial screw tab were broken due to over-tightening. The screw and the setscrew were replaced with a new one, however, the surgeon suspected failure of the screwdriver torque wrench ne160r. So he manually final tightened the setscrew without a torque handle, meaning that torque value of 10n/m is not assured. The surgeon was concerned about post-operative loosening of the screw. There was no patient harm. The surgery time was extended over 30 minutes. Patient information was not provided or was not available. The adverse event/malfunction is filed under (b)(4). Associated medwatch-reports: 9610612-2019-00979 ((b)(4) ne160r), 9610612-2019-00993 ((b)(4) sw790t), 9610612-2019-00995 ((b)(4) sw790t), 9610612-2019-00996 ((b)(4) sw790t).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00994 |
| MDR Report Key | 9759364 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2018-09-10 |
| Date Added to Maude | 2020-02-26 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | S4 SET SCREW NEW VERSION |
| Generic Name | SPINE SURGERY |
| Product Code | MNI |
| Date Received | 2020-02-26 |
| Returned To Mfg | 2020-02-11 |
| Model Number | SW790T |
| Catalog Number | SW790T |
| Lot Number | 52450608 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-02-26 |