S4 SET SCREW NEW VERSION SW790T

MAUDE Adverse Event Report

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.

Event Text Entries

[181371774] 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


[181371775] 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 surgical 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), 9610612-2019-00994 ((b)(4) sw790t), 9610612-2019-00995 ((b)(4) sw790t), 9610612-2019-00996 ((b)(4) sw790t).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2019-00993
MDR Report Key9759351
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-26
Date of Report2020-02-26
Date of Event2020-01-29
Date Mfgr Received2020-01-30
Device Manufacturer Date2019-07-05
Date Added to Maude2020-02-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMS KERSTIN ROTHWEILER
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal78501
Manufacturer G1AESCULAP AG
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal Code78501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameS4 SET SCREW NEW VERSION
Generic NameSPINE SURGERY
Product CodeMNI
Date Received2020-02-26
Returned To Mfg2020-02-11
Model NumberSW790T
Catalog NumberSW790T
Lot Number52527439
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-26

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