FDA.reportPublic FDA data

MAUDE MDR 6716751

MDR report key
6716751
Report number
1121308-2017-00010
Event key
0
Event type
3
Date received
2017-07-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
USER SONIA IRIZARRY
Address
311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US
Phone
609-609-6099
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IDRT-TS (INTL) SINGLE 4X5IDRT-TSINTEGRA LIFESCIENCES CORPORATIONMDD84051105NB0344891R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-170

Event Narratives#

N

Patient 1

INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON JULY 29, 2017. RESULTS: EVALUATION OF RETURNED DEVICE; THE PICTURES PROVIDED SHOW THAT THERE IS A FOLD IN THE SKIN UNIT. THEREFORE, THE FAILURE IS CONFIRMED EVEN THOUGH THE PRODUCT WAS NOT RETURNED BACK TO CMC FOR FAILURE ANALYSIS. DHR REVIEW; IDRT-TS (INTERNATIONAL) LOT 105NB0344891 WAS NOT FOLDED DURING THE PACKAGING PROCESS; THIS SHOWS THAT THE LOT WAS PLACED INTO THE PE SHEETS CORRECTLY AND THAT THERE WERE NO FOLDS IN THE SKIN DURING PACKAGING. COMPLAINTS HISTORY; THERE HAVE BEEN APPROXIMATELY (B)(4) IDRT-TS FAMILY UNITS SOLD IN THE PAST 12 MONTHS (MAY 2016 TO MAY 2017). AS PER THE TRENDING QUERIES, THERE HAS BEEN ONLY ONE (1) COMPLAINT IDENTIFIED FOR FOLDED PRODUCT SOLD (CURRENT COMPLAINT) FROM THE SKIN PRODUCT FAMILY. THEREFORE, THE CALCULATED COMPLAINT RATE IS (B)(4). CONCLUSION: THE ROOT CAUSE OF THIS COMPLAINT IS MOST LIKELY DUE TO HANDLING. THE ?FOLD/BENT? MOST LIKELY OCCURRED AFTER THE PACKAGING PROCESS. THERE ARE MULTIPLE PROCESSES AFTER PACKAGING THAT REQUIRE MANUAL HANDLING: SHIPPING TO THE STERILIZER, BACK FROM STERILIZER, AT THE DISTRIBUTION CENTER, TO THE CUSTOMER, ETC. THIS WAS ALSO CONFIRMED AS THE MOST LIKELY CAUSE BY THE PRODUCTION SUPERVISOR AT INTEGRA. INTEGRA HAS SOPS IN PLACE TO ENSURE THAT SKIN IS CAREFULLY HANDLED DURING PROCESSING, AND OPERATORS ARE TRAINED ON THESE SOPS. THESE SOPS ARE CONSIDERED SUFFICIENT FOR THEIR INTENDED PURPOSES. WITH THE PROCEDURES IN PLACE, IT IS MOST LIKELY THAT THE MISHANDLING OCCURRED AFTER SHIPMENT FROM INTEGRA.

D

Patient 1

IT WAS REPORTED THAT AFTER THE SKIN INCISION, THEY OPENED THE PACKAGING AND THE PRODUCT WAS BENT / FOLDED INSIDE THE INTERNAL PACKAGING. AS ONLY ONE UNIT WAS IN THE OR, THEY HAD TO USE IT. THEY USED ONLY THE PART WHICH WAS NOT BENT / FOLDED BY CUTTING IT AT THE PROPER SIZE. NO PATIENT HARM AND THE EVENT LEAD TO 10 MINUTES SURGICAL DELAY.