FDA.reportPublic FDA data

MAUDE MDR 5807095

MDR report key
5807095
Report number
2523190-2016-00116
Event key
0
Event type
3
Date received
2016-07-19
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
1STANDARD WISHBONE ASSEMBLYSURGICAL RETRACTORINTEGRA LIFESCIENCES CORPORATION OH/USAFFO4020157Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-07-190

Event Narratives#

N

Patient 1

TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

D

Patient 1

IT WAS REPORTED THAT THE COMPLAINT WAS ORIGINALLY TO FIX A RETRACTOR THAT WAS BECOMING LOOSE ON LARGER PATIENTS DURING SURGERY. NO PATIENT INJURY WAS REPORTED.

N

Patient 1

INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON SEPTEMBER 1ST, 2016. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: EVALUATION OF RETURNED DEVICE; THE RECEIVED UNIT IS NOW EXHIBITING SIGNS OF EXCESSIVE RESISTANCE DURING THE HANDLE THROW MOTION AND THE ROTATIONAL RESISTANCE OF THE WISHBONE ARMS THROUGH THEIR ENTIRE RANGE. DHR REVIEW; DEVICE HISTORY RECORD REVIEWED FOR THIS PRODUCT ID UNDER LOT CODE 157 SHOW NO ABNORMALITIES RELATED TO REPORTED INCIDENT FOUND. THESE DEVICE PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR?S, VARIANCES OR REWORK COMPLAINTS HISTORY; A TWO YEAR LOOKBACK FOR THIS REPORTED FAILURE AND OR RELATED TO " LOOSE ON LARGER PATIENTS DURING SURGERY, PARTS NOT READILY AVAILABLE AND LOANERS NOT AVAILABLE FOR THIS PRODUCT FAMILY" FOR THIS PRODUCT ID SHOWS THAT NO ADDITIONAL COMPLAINTS WERE RECEIVED. NO NEW DESIGN OR MANUFACTURING TRENDS HAVE BEEN IDENTIFIED. THIS ISSUE WILL BE MONITORED. CONCLUSION: THE DEFECTIVE UNIT IS BEING RETURNED FOR THE THIRD TIME. THE RECEIVED UNIT IS NOW EXHIBITING SIGNS OF EXCESSIVE RESISTANCE DURING THE HANDLE THROW MOTION AND THE ROTATIONAL RESISTANCE OF THE WISHBONE ARMS THROUGH THEIR ENTIRE RANGE. THE ROOT CAUSE FOR THE OBSERVED FAILURE CANNOT BE FULLY DETERMINED. THE UNIT DEMONSTRATES SIGNS OF BEING OVER TIGHTENED YET THERE AREN?T ANY SIGNS INDICATING THE 4032011 NUT BEING TAMPERED WITH WHILE OUT IN THE FIELD. FURTHERMORE, THE UNIT WAS COMPLETELY DISASSEMBLED WITH NO SIGNS OF INTERNAL COMPONENT DEFORMATIONS WHICH COULD BE IDENTIFIED AS A CONTRIBUTING FACTOR TO THE OBSERVED FAILURE.