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.
MAUDE MDR 5910456
- MDR report key
- 5910456
- Report number
- 2125289-2016-00002
- Event key
- 0
- Event type
- 3
- Date received
- 2016-08-29
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- 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 | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MULIER HIP RETRACTOR, 1 | SURGICAL RETRACTOR | INTEGRA LIFESCIENCES CORPORATION OH/USA | FFO | 4593 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-08-29 | 0 |
Event Narratives#
D
Patient 1
CUSTOMER PURCHASED THE OMNI HIP SYSTEM INCLUDING THE ABH STYLE LISTED ABOVE. ABH BLADE CONNECTORS HAVE BEGUN TO COME APART FROM THE BLADE. THESE SHOULD STAY INTACT WITH THE RETRACTOR BLADE. IMAGE ATTACHED. ONCE THESE CAME APART CUSTOMER NOTICED THAT BIOBURDEN WAS COLLECTING WHERE THESE SHOULD BE CONNECTED. ON (B)(6) 2016 CUSTOMER REPORTS THIS OCCURRED DURING A TOTAL HIP REPLACEMENT AND ALTHOUGH THERE WAS NO HARM THERE WAS POTENTIAL. NO FURTHER INFORMATION AVAILABLE #2 OF 5 RELATED COMPLAINTS.
N
Patient 1
METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - THE CUSTOMER?S COMPLAINT COULD NOT BE CONFIRMED BY ENGINEERING AS THE PHYSICAL PRODUCT WAS NOT RECEIVED FOR PROPER EVALUATION/INVESTIGATION. ACCORDING TO THE CUSTOMER THEIR MULIER/MEYERDING HIP RETRACTORS HAVE COME APART. THESE RETRACTORS COMPRISE OF TWO MAIN COMPONENTS (I.E. A SLOTTED BLADE AND ATTACHMENT) THAT GET PRESS FITTED TOGETHER TO FORM THE FINAL ASSEMBLY BUILD. DEVICE HISTORY EVALUATION - DEVICE HISTORY RECORD REVIEWED FOR THIS PRODUCT ID. A TOTAL OF 4 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. NO SERVICE HISTORY IS ON FILE FOR THIS DEVICE. CONCLUSION: ALTHOUGH THE CUSTOMER SUPPLIED PICTURES SHOWCASING THE REPORTED FAILURE, ENGINEERING IS YET TO RECEIVE THE DEFECTIVE UNITS FOR PROPER EVALUATION/INVESTIGATION. AS SUCH THE COMPLAINT CANNOT BE FULLY CONFIRMED AT THE MOMENT. IT SHOULD HOWEVER BE NOTED THAT THE CUSTOMER PREVIOUSLY REACHED OUT TO OUR SALES REPRESENTATIVE PRIOR TO THIS OFFICIAL COMPLAINT STATING THE FOLLOWING: ?APPARENTLY ONE OF THE SPD FOLKS AT AN ACCOUNT WAS TRYING TO REMOVE A BLADE FROM OUR ABH HOLDER PRIOR TO CLEANING, AND IN DOING SO, ACTUALLY POPPED THE NIPPLE COMPONENT OUT. THE CUSTOMER THEN APPARENTLY THOUGHT THAT THIS WAS A REQUIREMENT FOR CLEANING THE ABH BLADES, AND PROCEEDED TO BREAK APART ALL REMAINING BLADES PRIOR TO CLEANING. INTERESTINGLY ? THEY FOUND BIOBURDEN INSIDE THE COMPONENTS AFTER TAKING THE COMPONENTS APART?. EVALUATION OF THE PICTURE SHOWS THAT THE UPPER SEGMENT OF THE HIP BLADE ATTACHMENT OPPOSITE THE ?NIPPLE? FEATURE HAS SNAPPED IN HALF. THE CUSTOMER STATES THIS OCCURRED AS THEY WERE TRYING TO REMOVE THE BLADE FROM THE ABH HOLDER, WHICH HOLDS THE RETRACTOR IN PLACE UPON ENGAGEMENT VIA A SPRING PLUNGER IN THE BLADE HOLDER. THE NON-CONFORMANCE COULD POSSIBLY BE A RESULT OF FRACTURE LINES ON THE HIP ATTACHMENT WHICH WOULD EVENTUALLY YIELD AND FRACTURE UPON THE EXERTION OF FORCE DURING DISASSEMBLY, YET CANNOT BE CONFIRMED. THE ROOT CAUSE FOR THE REPORTED FAILURE CANNOT BE FULLY DETERMINED WITHOUT PHYSICALLY EVALUATING THE DEFECTIVE ASSEMBLY. FURTHERMORE, THE REPORTED PRESENCE OF BIOBURDEN STATED BY THE CUSTOMER CANNOT BE CONFIRMED AT THE MOMENT AS WELL, SINCE THE DEFECTIVE PRODUCT WAS NOT RECEIVED BY ENGINEERING AND THE PICTURES DO NOT SHOW ANY SIGNS OF CONTAMINATION IN THE AFFECTED AREAS. CURRENT INVENTORY PER ALL APPLICABLE PART NUMBERS HAVE BEEN INSPECTED AND VERIFIED TO BE CONFORMING WITH NO SIGNS OF FRACTURE LINES ON THE HIP ATTACHMENT WHICH COULD POSSIBLY LEAD TO THIS REPORTED FAILURE. THIS WILL BE CONSIDERED AN ISOLATED INCIDENT AND MONITORED FOR ANY FUTURE TREND
N
Patient 1
INTEGRA COMPLETED ITS INTERNAL INVESTIGATION 02/13/2017. THE INVESTIGATION INCLUDED: METHOD: DHR REVIEW: DEVICE HISTORY RECORD REVIEWED FOR THIS PRODUCT ID (4593) WORK ORDER / LOT # (B)(4) WERE MANUFACTURED ON 06/24/2014 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. NO SERVICE HISTORY IS ON FILE FOR THIS DEVICE. CONCLUSION: THE RECEIVED RETRACTORS HAVE CLEARLY BEEN INADVERTENTLY DISASSEMBLED BY THE END USER WITH THE (B)(4) ?HIP BLADE ATTACHMENT? COMPONENT COMPLETELY FORCED OFF THE HIP BLADE SLOTS. EVALUATION OF THE SUPPLIED PICTURE SHOWS THAT THE UPPER SEGMENT OF THE HIP BLADE ATTACHMENT OPPOSITE THE ?NIPPLE? FEATURE HAS SNAPPED IN HALF. THE CUSTOMER STATES THIS OCCURRED AS THEY WERE TRYING TO REMOVE THE BLADE FROM THE ABH HOLDER, WHICH HOLDS THE RETRACTOR IN PLACE UPON ENGAGEMENT VIA A SPRING PLUNGER IN THE BLADE HOLDER. THE NON-CONFORMANCE COULD POSSIBLY BE A RESULT OF FRACTURE LINES ON THE HIP ATTACHMENT WHICH WOULD EVENTUALLY YIELD AND FRACTURE UPON THE EXERTION OF FORCE DURING DISASSEMBLY, YET CANNOT BE CONFIRMED. THE ROOT CAUSE FOR THE REPORTED FAILURE CANNOT BE FULLY DETERMINED WITHOUT PHYSICALLY EVALUATING THAT DEFECTIVE ASSEMBLY. FURTHERMORE, THE REPORTED PRESENCE OF BIOBURDEN STATED BY THE CUSTOMER CANNOT BE FULLY CONFIRMED AS WELL. THE DEFECTIVE UNITS WENT THROUGH OUR STANDARD DECONTAMINATION PROCESS WHICH COULD HAVE POSSIBLY REMOVED ANY EVIDENCE OF BIOBURDEN. THE SUPPLIED PICTURES ALSO DO NOT SHOW ANY SIGNS OF CONTAMINATION IN THE AFFECTED AREAS. CURRENT INVENTORY PER ALL APPLICABLE PART NUMBERS HAVE BEEN INSPECTED AND VERIFIED TO BE CONFORMING WITH NO SIGNS OF FRACTURE LINES ON THE HIP ATTACHMENT WHICH COULD POSSIBLY LEAD TO THE REPORTED FAILURE. THIS WILL BE CONSIDERED AN ISOLATED INCIDENT AND MONITORED FOR ANY FUTURE TREND.