OLECRANON OSTEOTOMY END CAP
Report
- Report Number
- 2520274-2014-11797
- Event Type
- Injury
- Date Received
- June 12, 2014
- Report Date
- May 15, 2014
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HSB
- PMA / PMN Number
- PK073402
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NURSE
Narratives
A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE RETURNED NAIL, LOT # 5903749, WAS MANUFACTURED OCTOBER, 2009. IT WAS RECEIVED WITH THE THREADS BROKEN OFF AT THE BASE. THERE ARE THREAD MARKS IN THE DISTAL HOLE AND WEAR MARKS AROUND THE MIDDLE HOLE. IN ADDITION THERE ARE SCRAPS AROUND THE CIRCUMFERENCE OF THE NAIL AT THE LOCATION OF THE PROXIMAL HOLE. THE RETURNED END CAP, LOT # 5903342, WAS MANUFACTURED AUGUST, 2009. IT WAS RECEIVED WITH THE THREADED PORTION OF THE NAIL STUCK IN THE END CAP. THERE ARE ALSO SCRATCHES ON THE SURFACE OF THE CAP AND THE DRIVE IS WORN. THE COMPLAINT CONDITION CANNOT BE REPLICATED SINCE THE NAIL IS ALREADY BROKEN AND THE SCREWS WERE NOT RETURNED. THE COMPLAINT CONDITION IS CONFIRMED BECAUSE THE NAIL WAS RECEIVED BROKEN AND THE X-RAYS CONFIRM THE BROKEN SCREWS. BASED ON THE WEAR ON THE DEVICES, THE X-RAYS, AND THE INFORMATION REPORTED IN THE COMPLAINT IT WAS DETERMINED THAT THE MOST LIKELY CONFIGURATION OF IMPLANTS WAS A 2.7MM X 20MM THREADED STEPPED SCREW, PART NUMBER 02.007.020, IN THE DISTAL HOLE AND A 2.7MM X 26MM THREADED STEPPED SCREW, PART NUMBER 02.007.026, IN THE PROXIMAL HOLE OF THE OLECRANON OSTEOTOMY NAIL. A 2.7MM/3.5MM VA-LCP EXTENDED MEDIAL DISTAL HUMERUS PLATE, PART NUMBER 02.117.602, WAS IMPLANTED WITH A 2.7MM X 68MM METAPHYSEAL SCREW, PART NUMBER 02.118.568, IN THE FIRST HOLE, A 2.7MM X 30MM METAPHYSEAL SCREW, PART NUMBER 02.118.530, IN THE SECOND HOLE, AND A 2.7MM X 70MM METAPHYSEAL SCREW, PART NUMBER 02.118.570, IN THE THIRD HOLE FROM THE PROXIMAL END. A 3.5MM X 16MM CORTICAL SCREW, PART NUMBER 204.816, WAS USED IN THE MOST DISTAL HOLE AND A 3.5MM X 26MM CORTICAL SCREW, PART NUMBER 204.826, WAS USED IN THE SECOND HOLE FROM THE DISTAL END. THUS, THE BROKEN SCREWS ARE LIKELY PART NUMBERS 204.826 AND 02.118.568. THE BREAKS ARE CONSISTENT WITH THE RESULT OF EXCESSIVE SHEAR FORCES AND IT IS LIKELY THAT PATIENT ACTIVITY AND COMPLIANCE OR INCOMPLETE REDUCTION OF THE FRACTURE IMPACTED THE COMPLAINT CONDITION. LOADS PRODUCED BY WEIGHT BEARING AND ACTIVITY LEVELS WILL DICTATE THE LONGEVITY OF THE IMPLANT. IN ABSENCE OF SOLID BONY UNION, THE WEIGHT OF THE LIMB ALONE, MUSCULAR FORCES ASSOCIATED WITH MOVING A LIMB, OR REPEATED STRESSES OF APPARENT RELATIVE SMALL MAGNITUDES, CAN RESULT IN FAILURE OF THE IMPLANT. THE RETURNED PARTS WERE MANUFACTURED AFTER THE RELEASE OF THE CURRENT DRAWING REVISION. THEREFORE, A REVIEW OF THE CURRENT EDITION OF THE DESIGN DRAWINGS, 02_007_001 REV. B AND 02_007_002 REV. C, WERE PERFORMED. THE DESIGNS WERE FOUND TO BE SUFFICIENT FOR THEIR INTENDED USE AND THE COMPLAINT CONDITION IS NOT THE RESULT OF A DESIGN DEFICIENCY. THUS, SINCE IT IS UNCLEAR HOW THE BREAKAGE HAPPENED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
THE IMPLANT RECORD HISTORY SUBMITTED BY THE USER FACILITY WITH PART NUMBER INFORMATION CONTAINS AN IMPLANT NOTATION IN THE RECORD OF (B)(4) 2013, THE RECORD ALSO INDICATES THE YEAR AS 2014 IN THE HEADER INFORMATION. THE INITIAL REPORT, ALSO INDICATES THE YEAR AS 2014. THIS DATE HAS BEEN VERIFIED BY THE SALES CONSULTANT AS CORRECT. THE DATE OF (B)(4) 2014 HAS BEEN ENTERED INTO THIS RECORD AS THE IMPLANT DATE. THIS INFORMATION IS ONLY MEANT AS CLARIFICATION OF THE CONFLICTING DATES WITHIN THE QUALITY RECORD. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: SYNTHES (B)(4) MANUFACTURED THE OLECRANON OSTEOTOMY NAIL, 02.007.002, AND LOT NUMBER 5903342. THERE WERE NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES WITH THIS LOT.DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED THE PATIENT SUFFERED A RIGHT DISTAL HUMERUS FRACTURE ON AN UNKNOWN DATE AND UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) AND OLECRANON OSTEOTOMY ON (B)(6) 2014. THE PATIENT RETURNED POST OPERATIVELY WITH NONUNION AND BROKEN HARDWARE. THE OLECRANON OSTEOTOMY NAIL BROKE AND THE NAIL END CAP JUNCTION. ONE OF THE 3.5MM CORTEX SCREWS AND A 2.7MM VARIABLE ANGLE LOCKING SCREW BROKE THAT WERE THROUGH THE MEDIAL DISTAL HUMERUS PLATE. ALL BROKEN HARDWARE WAS REMOVED EXCEPT ONE OF THE BROKEN 3.5MM CORTEX SCREWS. THE DISTAL HUMERUS WAS REVISED ON (B)(6) 2014 WITH 4.5MM RECON PLATE AND OLECRANON OSTEOTOMY WAS PLATED WITH 2.7MM/3.5MM VARIABLE ANGLE OLECRANON 4 HOLE PLATE. THE PATIENT IS STABLE AND THERE WERE NO COMPLICATIONS DURING SURGERY. THIS IS REPORT 2 OF 4 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 347291 | OLECRANON OSTEOTOMY END CAP | ROD,FIXATION,INTRAMEDULLARY | HSB | SYNTHES MONUMENT | 5903342 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |