TI MATRIXRIB PRE-CONTOURED PL 17 HOLES FOR RIGHT RIBS 6 & 7
Report
- Report Number
- 8030965-2013-00119
- Event Type
- Injury
- Date Received
- January 14, 2013
- Report Date
- December 14, 2012
- Manufacturer
- SYNTHES GMBH
- Product Code
- HRS
- PMA / PMN Number
- K081623
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
MDR DETERMINATION REVISED; EXPLANT SURGERY PERFORMED.
A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED. FROM A DESIGN PERSPECTIVE, THERE ARE SEVERAL POTENTIAL CAUSES OF PLATE BREAKAGE INCLUDING SURGICAL TECHNIQUE, BONE QUALITY, PATIENT COMPLIANCE, DEVICE MATERIAL PROPERTIES AND DEVICE DESIGN. THE CASE WAS DISCUSSED WITH THE SALES CONSULTANT AND HE DID NOT NOTE ANY PROBLEMS WITH THE SURGICAL TECHNIQUE NOR WITH PATIENT NON-COMPLIANCE. THE SALES CONSULTANT DID CONFIRM THAT THE BONE WAS HEALED WHEN THE DEVICE WAS REMOVED. IT SHOULD BE NOTED THAT THE DEVICE HAD BEEN IMPLANTED FOR OVER 2 YEARS BASED ON THE PROVIDED IMPLANTATION DATE AND SINCE THE BONE WAS HEALED, THIS SUGGESTS THE DEVICE BROKE AFTER BONE HEALING. WITH THIS INFORMATION, IT IS DIFFICULT TO DETERMINE AN EXACT CAUSE, BUT THE MATERIAL PROPERTIES AND THE DESIGNED STRENGTH OF THE PLATES CAN ALSO BE CONSIDERED. THE MATERIAL SELECTED FOR THIS PLATE IS (B)(4) WHICH IS A STANDARD MATERIAL FOR THIS TYPE OF DEVICE AND IS USED FOR ITS BIOCOMPATIBILITY AND STRENGTH. IN TERMS OF DESIGN, THE STRENGTH OF THESE PLATES WAS VERIFIED AND VALIDATED VIA MECHANICAL AND CADAVERIC BEND TESTING TO MEET THE DESIGN CRITERION OF BEING COMPARABLE TO THE NATIVE STRENGTH OF RIBS OF OSTEOPOROTIC BONE QUALITY. THIS DESIGN CRITERION WAS CHOSEN TO MITIGATE THE RISK FOR SCREW PULL-OUT AND PERIPROSTHETIC FRACTURE ESPECIALLY IN PRESENCE OF OSTEOPOROTIC BONE. THE DESIGN OF THE PLATE WAS VERIFIED AND VALIDATED TO MEET THE DESIGN CRITERIA. OCCUPATION CORRECTED FROM OTHER TO OTHER HEATHCARE PROFESSIONAL. PLACEHOLDER.
THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. NOT ALL RELEVANT DIMENSIONS CAN BE VERIFIED ANYMORE DUE TO THE DAMAGE. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. BASED ON THE ADDITIONAL INFORMATION FROM THE PD EVALUATION AND THE APPEARANCE OF THE FRACTURE FACE WE SUPPOSE THAT DYNAMIC BENDING LOADS OVER A LONG PERIOD OF TIME CAUSED A FATIGUE BREAKAGE OF THE PLATE.
DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION ALSO COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
THIS IS 1 OF 2 REPORTS FOR COMPLAINT (B)(4).
INITIALLY REPORTED: A REPORT WAS RECEIVED ON (B)(4) 2012 OF A PATIENT WITH A BROKEN MATRIX RIB PLATE (6TH/7TH RIB). UPDATE: THE PLATES AND SCREWS WERE REMOVED FROM THE PATIENT ON (B)(6) 2013. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.
IT WAS REPORTED BY THE SALES CONSULTANT THAT: ON (B)(6) 2012 THE SURGEON INFORMED HIM OF A PATIENT WITH A BROKEN MATRIX RIB PLATE (6TH/7TH RIB). THE SURGEON PLANS TO REVISE THE PATIENT AND REMOVE THE PLATE ON AN UNKNOWN DATE IN (B)(6) 2013. PRODUCT LOT NUMBER AND ADDITIONAL INFORMATION WILL BE PROVIDED UPON REVISION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21363 | TI MATRIXRIB PRE-CONTOURED PL 17 HOLES FOR RIGHT RIBS 6 & 7 | TI MATRIXRIB PRE-CONTOURED PL | HRS | SYNTHES GMBH | 3507162 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |