FDA.reportPublic FDA data

MAUDE MDR 9882723

MDR report key
9882723
Report number
0001822565-2020-01112
Event key
0
Event type
3
Date of event
2020-03-04
Date received
2020-03-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
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
1LINKED LAG SCREW INSERTERINSTRUMENT, TRAUMAZIMMER BIOMET, INC.HWRN/A0011930120061167516N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2601. O

Event Narratives#

N

Patient 1

(B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

D

Patient 1

IT WAS REPORTED DURING AN INITIAL PROCEDURE THAT THE LAG SCREW INSERTER BROKE OFF IN THE PATIENT. BROKEN PORTION OF THE INSERTER WAS NOT RETRIEVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.