FDA.reportPublic FDA data

MAUDE MDR 9841838

MDR report key
9841838
Report number
9610612-2020-00078
Event key
0
Event type
3
Date of event
2020-02-26
Date received
2020-03-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS KERSTIN ROTHWEILER
Address
PO BOX 40 TUTTLINGEN, 78501 GM
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ENNOVATE TORQUE WRENCH HANDLE 10NMINSTRUMENTS POSTERIOR STABILISATIONAESCULAP AGHXCSZ228RSZ228R52339213Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1701. R

Event Narratives#

N

Patient 1

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

D

Patient 1

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).