FDA.reportPublic FDA data

MAUDE MDR 6065026

MDR report key
6065026
Report number
2125289-2016-00009
Event key
0
Event type
3
Date received
2016-10-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
USER SANDRA LEE
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
1OMNI-FLEX STERILE FIELD POSTSURGICAL RETRACTORINTEGRA LIFESCIENCES CORPORATION OH/USAFFO10244154Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-10-280

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

POST IS ROTATING/ SLIPPING DURING SURGERY. ON (B)(6) 2016 CUSTOMER HAS NO FURTHER INFORMATION.

N

Patient 1

INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 12/21/2016 . THE INVESTIGATION INCLUDED: DEVICE HISTORY RECORD REVIEWED FOR THIS PRODUCT ID LOT #161 MANUFACTURED ON APRIL 11, 2016, LOT# 164 MANUFACTURED ON JUNE 19, 2016 AND LOT# 167 MANUFACTURED ON OCTOBER 05, 2016 SHOW NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. THE DEVICES MANUFACTURED DURING THIS PERIOD PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR?S, VARIANCES OR REWORK. ENGINEERING NOTICED THE S.F. CLAMP SUBASSEMBLY (P/N 4088021) WAS NOT FUNCTIONING PROPERLY AS DESIGNED. THE S.F CLAMP SUBASSEMBLY PRIMARILY COMPRISES OF TWO .75 SERRATED CLAMPS (P/N 4044011), WHICH LOCK TOGETHER WHEN THE HANDLE IS PLACED IN THE LOCKED POSITION. IN THE LOCKED POSITION, THE STARBURST TEETH DO FULLY ENGAGE WITH NO VISIBLE GAPS PRESENT AND THE HANDLE DOES NOT ALIGN PARALLEL TO THE FIELD POST. IN THE UNLOCKED POSITION WITH THE APPLICATION OF FORCE ON THE CLAMP?S HANDLE, THE STARBURST TEETH DO FULLY ENGAGE AS WELL AND THE HANDLE REMAINS UNPARALLELED TO THE POST, YET THE CAM BODY (P/N 4047011) DOES NOT FULLY SIT ON THE BUSHING (P/N 4103011) BETWEEN THE .75 SERRATED CLAMP AND CAM BODY AS IT SHOULD. DYSFUNCTIONAL INTERNAL COMPONENTS WITHIN AND ON THE 4088021 ?S.F. CLAMP SUBASSEMBLY, .75 X .75 SERRATED?, DUE TO USER ERROR, IS THE PRIMARY CAUSE FOR THE REPORTED SLIPPAGE/ROTATION DURING SURGERY. THERE?S A POSSIBILITY THAT THE 4088021 ?S.F CLAMP SUBASSEMBLY? PREMATURELY FAILED DUE TO INITIAL GALLING WHICH COULD OF OCCURRED DURING OUR INTERNAL ASSEMBLY PROCESS, CAUSING LOSS OF FUNCTIONALITY AS EXTENSIVE GALLING/WEAR IS ENHANCED AS THE HANDLE IS EXERCISED OVER TIME. PER THE INSTRUCTIONS FOR USE (IFU) THE END USER IS EDUCATED NOT TO FORCE THE HANDLE PAST THE STOP POINT; CAPA HAS BEEN ISSUED TO ADDRESS THE NON-CONFORMANCE ABOVE, AND TO HELP ADOPT MEASURES TO HELP PREVENT ANY FUTURE REOCCURRENCES.