FDA.reportPublic FDA data

MAUDE MDR 6691018

MDR report key
6691018
Report number
0001825034-2017-04225
Event key
0
Event type
3
Date of event
2017-06-08
Date received
2017-07-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. CHRISTINA ARNT
Address
56 E. BELL DR. WARSAW IN 46582 US
Phone
574-574-5745
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TOGGLELOC/WASHERLOC DISPOSABLE KITKIT, SURGICAL INSTRUMENT, DISPOSABLEBIOMET SPORTS MEDICINEKDDN/A909846318780R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-0601. O

Event Narratives#

N

Patient 1

PT IDENTIFIER: - (B)(6). DEVICE PRODUCT CODE - KDD. UDI NUMBER - (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

D

Patient 1

IT HAS BEEN REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, METAL SHAVINGS WERE NOTICED IN THE KNEE JOINT AFTER USING THE 2.4MM DRILL TIP PIN FROM THE KIT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

N

Patient 1

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

D

Patient 1

IT HAS BEEN REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, METAL SHAVINGS WERE NOTICED IN THE KNEE JOINT AFTER USING THE 2.4MM DRILL TIP PIN FROM THE KIT. IT IS UNKNOWN IF ALL METAL SHAVINGS WERE SUCCESSFULLY REMOVED.

N

Patient 1

THE COMPLAINT SAMPLE WAS EVALUATED, BUT THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DEVIATIONS RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. A COMPLAINT HISTORY SEARCH WAS PERFORMED AND NO ACTIONS ARE REQUIRED. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED.