FDA.reportPublic FDA data

MAUDE MDR 5721308

MDR report key
5721308
Report number
2523190-2016-00081
Event key
0
Event type
3
Date of event
2016-05-13
Date received
2016-06-13
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 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
12016-06-130

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

CUSTOMER REPORTS THE POST IS ROTATING/ SLIPPING DURING SURGERY.. ON (B)(6) 2016 CUSTOMER REPORTS THE SURGEON WAS PERFORMING A WHIPPLE PROCEDURE, NO HARM TO PATIENT.

N

Patient 1

ON 6/13/16 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - THE CUSTOMERS? COMPLAINT HAS BEEN CONFIRMED BY ENGINEERING. HOWEVER IT SHOULD BE NOTED THAT THIS FIELD POST IS BEING RETURNED FOR SERVICING FOR THE FIRST TIME SINCE BEING REPLACED Q1 OF 2016. THE SERRATED S.F CLAMP DOES LOCK ONTO THE POST CLAMP WELD ASSEMBLY BUT ROTATES ON THE POST WHEN A SUBSTANTIAL AMOUNT OF FORCE IS APPLIED. FURTHERMORE THE CLAMP?S SUBASSEMBLY HANDLE DOES NOT ALIGN PARALLEL TO THE FIELD POST IN BOTH LOCKED AND UNLOCKED POSITIONS. ALTHOUGH IN THE UNLOCKED POSITION FORCE IS REQUIRED TO CAUSE THE MISALIGNMENT .THERE IS VISIBLE WEAR AND TEAR ON THE RETURNED UNIT. DEVICE HISTORY EVALUATION - DEVICE RECORD REVIEWED FOR THIS PRODUCT ID SHOW NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. THE DEVICES MANUFACTURED PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR?S, VARIANCES OR REWORK. CONCLUSION: S.F. CLAMP SUBASSEMBLY WAS NOT FUNCTIONING PROPERLY AS DESIGNED. THE S.F CLAMP SUBASSEMBLY PRIMARILY COMPRISES OF TWO .75 SERRATED CLAMPS 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 DOES NOT FULLY SIT ON THE BUSHING BETWEEN THE .75 SERRATED CLAMP AND CAM BODY AS IT SHOULD. DYSFUNCTIONAL INTERNAL COMPONENTS WITHIN AND ON THE ?S.F. CLAMP SUBASSEMBLY, .75 X .75 SERRATED?, DUE TO USER ERROR, IS THE PRIMARY CAUSE FOR THE REPORTED SLIPPAGE/ROTATION DURING SURGERY. THE CAM BODY IS SUPPOSED TO FULLY SIT ON THE BUSHING AT ALL TIMES IN BOTH LOCKED AND UNLOCKED POSITIONS. THE HANDLE SHOULD ALWAYS REMAIN PARALLEL TO THE FIELD POST WHEN FULLY ROTATED TO EITHER END. THE HANDLE SHOULD ONLY HAVE THE ABILITY TO ROTATE BETWEEN 0? AND 180?, EVEN WITH THE APPLICATION OF FORCE. FORCING THE HANDLE BEYOND THE 180? RANGE OF MOTION (R.O.M) DOES NOT ENHANCE THE LOCKING MECHANISM CLAMP SUBASSEMBLY? ON THE POST. ON THE CONTRARY DOING SO RESULTS IN EXTRA STRESSES BEING PLACED ON THE ?CAM BODY?, ?CAM BOLT BUSHING? AND THE ?HANDLE? AS WELL, LEAVING PERMANENT DEFORMATION IN ITS WAKE. AS A RESULT OF THIS DEFORMATION, INTERNAL MATING COMPONENTS LOSE THE NECESSARY CONTACT/TRACTION REQUIRED TO FUNCTION AS INTENDED. AS SEEN BELOW, THE END USER FORCED THE ?HANDLE? BEYOND THE ALLOWABLE R.O.M CREATING A SIGNIFICANT INDENTATION ON THE ?CAM BODY? AND HANDLE. THE AMOUNT OF FORCE USED TO FORM THESE DEEP INDENTATIONS ON THE CAM BODY AND HANDLE WAS SO EXCESSIVE THAT THE CIRCULAR ?CAM BOLT BUSHING? BECAME SIGNIFICANTLY DEFORMED, AS WELL AS THE CAM FEATURE ON THE ?HANDLE?. PER THE INSTRUCTIONS FOR USE (IFU) THE END USER IS EDUCATED NOT TO FORCE THE HANDLE PAST THE STOP POINT;