FDA.reportPublic FDA data

MAUDE MDR 8612578

MDR report key
8612578
Report number
0001822565-2019-02040
Event key
0
Event type
3
Date of event
2019-04-25
Date received
2019-05-15
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
1CABLE CUTTER 1.8 MM MAXIMUM CABLE DIAMETERTRAUMA- INSTRUMENTZIMMER BIOMET, INC.HXZ0039250110064218646Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-150

Event Narratives#

N

Patient 1

(B)(4). REPORT SOURCE: (B)(6). 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. PRODUCT NOT RETURNED.

D

Patient 1

IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE CUSTOMER RECEIVED A NEW PRODUCT BUT THE CABLE CUTTER DOES NOT CUT THE CABLE PROPERLY. CUTTING SURFACES ARE NOT SHARP ENOUGH. THE CUTTER WAS TESTED IMMEDIATELY AT THE RECEPTION AFTER OPENING FROM THE PACKAGE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.