FDA.reportPublic FDA data

MAUDE MDR 7252519

MDR report key
7252519
Report number
0001825034-2018-00403
Event key
0
Event type
3
Date of event
2017-11-03
Date received
2018-02-08
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
1BMP SLEEVE GRIP CRIMPERCRIMPER, PINZIMMER BIOMET, INC.HXQN/A498003082320Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-02-080

Event Narratives#

N

Patient 1

(B)(4). REPORT SOURCE, FOREIGN ? EVENTS OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

D

Patient 1

IT WAS REPORTED THAT DURING USE, THE TIP OF THE INSTRUMENT BROKE; HOWEVER, THE SURGERY TOOK PLACE NORMALLY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.