FDA.reportPublic FDA data

MAUDE MDR 9860770

MDR report key
9860770
Report number
3006108336-2020-00005
Event key
0
Event type
3
Date of event
2020-02-21
Date received
2020-03-20
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 SHIMA HASHEMIAN
Address
16597 N 92ND STREET 101 SCOTTSDALE AZ 85260 US
Phone
480-480-4805
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1QUATTRO SUTURE PASSER NEEDLENEEDLECAYENNE MEDICALGABN/ACM-901170418-1R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2001. R

Event Narratives#

N

Patient 1

CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION BECAUSE DEVICE WAS SCRAPPED BY CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE COMPLAINT WAS NOT CONFIRMED. 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 WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, A SUTURE PASSER NEEDLE CM-9011 FRACTURED. THE FRACTURED PIECE WAS NOT LOCATED INSIDE OR OUTSIDE THE PATIENT AND IT COULD HAVE REMAINED INSIDE THE PATIENT. 45 MINUTE SURGICAL DELAY WAS REPORTED FOR THIS EVENT.