FDA.reportPublic FDA data

MAUDE MDR 9631457

MDR report key
9631457
Report number
3005751028-2020-00008
Event key
0
Event type
3
Date of event
2019-10-01
Date received
2020-01-27
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
MR. WILLIAM HARA
Address
10 POMEROY ROAD PARSIPPANY NJ 07054 US
Phone
973-973-9735
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CURVED OSTEOTOMEINSTRUMENT, SURGICALZIMMER TMTHWMN/A0070530030163396488Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-2701. H

Event Narratives#

N

Patient 1

(B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED DEVICE IDENTIFIED THAT THE CLAMPING SCREW WAS NO LONGER FUNCTIONING AS INTENDED, AS IT WOULD NOT TIGHTEN. THE HEX THREADS INSIDE THE SCREW WERE DAMAGED LIKELY FROM TIGHTENING THE SCREW. THE DEVICE HAD AN APPROXIMATE FIELD LIFE OF 3 YEARS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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. REPORT SOURCE: EVENT OCCURRED IN (B)(6).

D

Patient 1

IT WAS REPORTED THAT DURING A PRIMARY THA, THE INSTRUMENT WOULD NOT HOLD THE BLADE COMPONENT. THE SURGEON WAS UNABLE TO USE THE DEVICE AND PROCEEDED TO USE A CHISEL FOR SURGERY. THIS RESULTED IN A 31-60 MINUTE DELAY IN SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.