BC DISTRACTOR BODY END ACT. W/U-JOINT 25MM FOR CMF DSTR
Report
- Report Number
- 2530088-2013-01042
- Event Type
- Injury
- Date Received
- July 12, 2013
- Report Date
- January 28, 2013
- Manufacturer
- SYNTHES BRANDYWINE
- Product Code
- MQN
- PMA / PMN Number
- K060138
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). PATIENTS WEIGHT AT THE TIME OF THE SURGERY ON (B)(6) 2013 WAS (B)(6). ADDITIONAL PART WAS ADDED ON (B)(6) 2013. A MANUFACTURING EVALUATION WAS CONDUCTED. THE REPORT INDICATES THE DEVICE WAS RECEIVED WITH SEVERAL LARGE SCRATCHES, SOME SMALL SCRATCHES AND TOOL MARKS ON THE DISTRACTOR BODY INDICATIVE OF USE. THE 04.315.000 MACHINE SCREW SUB-COMPONENT SHOWS MARKS AND DEFORMATION OF THE SCREWDRIVER SLOTS INDICATIVE OF USE. THE LASER MARKING IS LEGIBLE AND CLEAR. THERE IS DEBRIS VISIBLE ON THE ACTIVATION SCREW. THE DISTRACTOR HAS TWO FOOT PLATES ATTACHED TO IT, 04.315.20 (LAST NUMBER CUT OFF), LOT NUMBER U148154 AND 04.315.203, LOT NUMBER U148725. THE FOOT PLATES ARE CUT AND BENT. THE FOOT PLATES EXHIBIT TOOL MARKS AND WORN ANODIZE INDICATIVE OF USE. THE DISTRACTOR DOES NOT DISTRACT TO ANY DEGREE. THE 04.315.065 PASSES FOR THE L2, L4 AND D1 AND RAW MATERIAL FEATURES. THE L1 IS OVERSIZED DUE TO THE ASSEMBLED STATE WITH THE MESH PLATES. THE L3 AND L5 FEATURES ARE UNOBTAINABLE DUE TO DAMAGE TO THE PART OR THE ASSEMBLED STATE OF THE DISTRACTOR WITH THE MESHPLATES. THE PARTS FAIL THE FUNCTIONAL TEST AS THE DISTRACTOR BINDS WHEN THE MESH PLATES ARE 10MM APART. THERE IS DEBRIS IN THE U-JOINT SCREW ASSEMBLY. MORE TESTING IS NEEDED BY PRODUCT DEVELOPMENT TO DETERMINE THE CAUSE OF THE FAILURE OF THE DISTRACTOR. REVIEW OF DEVICE HISTORY RECORD, PART NUMBER 04.315.065 SHOWED NO EVIDENCE DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT. REVIEW OF THE RAW MATERIAL LOT NUMBERS, 6066660, 6905463, 6625107 AND 9986 DID NOT PROVIDE ANY EVIDENCE THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. INVESTIGATION IS ON-GOING.
DATE OF UNKNOWN X-RAY REVEALING REVERSAL OF DISTRACTORS WAS (B)(6), 2013. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.
THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE RESULTS OF THE PRODUCT DEVELOPMENT EVALUATION ARE AS FOLLOWS: AS DESCRIBED IN THE COMPLAINT DESCRIPTION AND SEEN ON THE ATTACHED X-RAY IMAGES, TWO (2) DISTRACTOR ASSEMBLIES WERE IMPLANTED BILATERALLY ON THE PATIENT¿S MANDIBLE IN THE RETRACTED CONDITION. THE FOOTPLATES AND THE DISTRACTOR BODY APPEARED TO BE ASSEMBLED AS DESCRIBED IN STEP 3B OF THE CMF DISTRACTION SYSTEM TECHNIQUE GUIDE (J7415-D) (REFER TO PAGE 14-15); WITH THE C-TYPE FOOTPLATE ATTACHED AT THE END OF THE DISTRACTOR BODY AND THE B-TYPE FOOTPLATE ASSEMBLED ALONG THE LEAD SCREW OF THE DISTRACTOR BODY. THE SECOND DISTRACTOR BODY ASSEMBLY WAS DISASSEMBLED. PARTS WERE EXAMINED UNDER 10X MAGNIFICATIONS. THE B-TYPE FOOTPLATE SHOWED SIGNS OF ¿RUBBING¿ INSIDE THE DISTRACTOR BODY AS EVIDENT BY ANODIZE REMOVAL ON THE OD OF THE THREAD PORTION OF THE FOOTPLATE; IT IS UNCLEAR WHEN AND UNDER WHAT CONDITIONS THIS RUBBING OCCURRED. THERE WAS NO DISCERNABLE DIFFERENCE IN THE APPEARANCE OF THE SCREW. THE INTERNAL FEATURES OF THE DISTRACTOR BODY COULD NOT BE EVALUATED WITHOUT DESTRUCTIVELY BREAKING THE WELDED ASSEMBLY. THE COMPLAINT CONDITION OF REVERSING CAN BE DUPLICATED ON BOTH RETURNED DISTRACTOR BODIES. FIRST THE FOOTPLATES WERE HELD IN AXIAL COMPRESSION SIMILAR TO THE EXPECTED DIRECTION DURING CONSOLIDATION. SECONDLY THE ACTIVATION END OF THE DISTRACTOR WAS ROTATED CLOCKWISE WITHOUT REVERSING OF THE FOOTPLATE (THIS OCCURRED WITHIN CERTAIN REGIONS OF TRAVEL) RESULTING IN A GAP BETWEEN THE HEAD OF THE ADVANCEMENT SCREW (04_315_062_1) AND END CAP (04_315_062_2). THIS GAP IS DUE TO THE ALLOWABLE BACKLASH IN THE DESIGN; THE ALLOWABLE BACKLASH FOR THE BC U-JOINT DISTRACTOR BODY IS 0.130MM TO 0.340MM; THE GAP ON THE RETURNED DISTRACTOR BODIES WAS MEASURED USING AN OPTICAL COMPARATOR TO BE 0.250MM AND 0.271MM. CLINICALLY THE ROTATIONAL MICROMOTION OF THE SCREW MAY BE ATTRIBUTED TO PATIENT MOTION AND VIBRATIONS FROM THE SURROUNDING ENVIRONMENT. WITH DECREASED ROTATIONAL FRICTION BETWEEN THE SCREW AND THE FOOTPLATE THERE IS AN INCREASED POSSIBILITY OF MICROMOTION. LASTLY WHEN AN EXTERNAL FORCE IS APPLIED TO THE ACTIVATION END OF THE DISTRACTOR BODY, THE B-TYPE FOOTPLATE SHIFTS/REVERSES THE GAP DISTANCE. LARGER REVERSING DISTANCES CAN BE ACHIEVED BY REPEATING THE DESCRIBED REVERSING MECHANISM. IT SHOULD ALSO BE NOTED THAT IF THE ROTATIONAL FRICTION IS LOW ENOUGH, REVERSING CAN OCCUR JUST FROM THE MICROMOTION OF THE SCREW. THEREFORE IT CAN BE CONCLUDED THAT THE NOTED REVERSING OF THE CMF DISTRACTOR BODIES IS DESIGN RELATED. THE ALLOWABLE BACKLASH IN THE DISTRACTOR BODY, THE LOW ROTATIONAL FRICTION WITHIN THE SCREW/FOOTPLATE THREAD AND THE INTERFACE BETWEEN THE FOOTPLATE AND DISTRACTOR BODY ARE CONTRIBUTING DESIGN FEATURES WITH RESPECT TO THIS COMPLAINT. EXTERNAL FACTORS SUCH AS ANATOMIC PLACEMENT OF THE DEVICE, AGE OF THE PATIENT AND POST-SURGICAL ROUTINE MAY HAVE ALSO CONTRIBUTED TO THE NOTED FAILURE. THE NOTED TLA (TONGUE/LIP ADHESION) PROCEDURE IS NOT UNCOMMON UNDER CERTAIN MEDICAL CIRCUMSTANCES. IT IS NOT CLEAR THAT THE REVERSING OF THE DISTRACTORS OR THE SURGICAL REACTIVATION PROCEDURE RESULTED IN THE PATIENT ARRESTING NECESSITATING THE TLA PROCEDURE. THEREFORE FROM A DESIGN PERSPECTIVE THIS COMPLAINT CONDITION IS VALID BECAUSE MECHANISM OF REVERSING CAN BE DUPLICATED AND IS RELATED TO THE DESIGN. THE ALLOWABLE BACKLASH IN THE DISTRACTOR BODY, THE LOW ROTATIONAL FRICTION WITHIN THE SCREW/FOOTPLATE THREAD AND THE INTERFACE BETWEEN THE FOOTPLATE AND DISTRACTOR BODY ARE CONTRIBUTING DESIGN FEATURES WITH RESPECT TO THIS COMPLAINT.
THE PATIENT HAS MANDIBULAR HYPOPLASIA AND ON (B)(6) 2012, A CMF DISTRACTOR WAS IMPLANTED. IT WAS NOTICED ON AN X-RAY, EXACT DATE UNKNOWN, THAT THE DISTRACTOR STARTED TO REVERSE. THE PATIENT HAD BEEN AT THE DESIRED LENGTH OF 20MM OF DISTRACTION AND ALL OF THE SUDDEN, ONE SIDE REVERSED BACK TO 10MM AND THE OTHER SIDE REVERSED BACK TO 5 OR 6MM. THE SURGEON BROUGHT THE PATIENT BACK TO THE O.R. ON (B)(6) 2013 TO REACTIVATE THE DISTRACTOR TO THE PROPER LENGTH. IT WILL BE LEFT IN FOR ABOUT TWO MONTHS TO ALLOW THE BONE TO SOLIDIFY AND ANOTHER SURGERY WILL BE SCHEDULED TO REMOVE THE DISTRACTOR IN APPROXIMATELY APRIL. THE PATIENT IS A NEONATE AND HAS BEEN IN ICU SINCE THE ORIGINAL SURGERY. IT WAS NOTED THAT ONLY THE SURGEON AND THE NURSES ACTIVATED THE DISTRACTOR AND THE PARENTS DID NOT TOUCH IT. AFTER SURGERY ON (B)(6) 2013 PATIENT ARRESTED, AIRWAY CONSTRICTED; SURGEON HAD TO INTERVENE AND PERFORM A TLD, TONGUE AND LIP ADHESION. PATIENT REPORTEDLY RECOVERING AND WILL UNDERGO ANOTHER SURGERY TO REMOVE THE DISTRACTOR IN APPROXIMATELY (B)(6). IT WAS REPORTED THAT THE PATIENT HAD SURGERY ON (B)(6) 2013 FOR THE REMOVAL OF ALL MANDIBULAR HARDWARE WHICH INCLUDED A LEFT AND RIGHT DISTRACTOR AND 4 FOOT PLATES. ADDITIONAL HARDWARE WAS NOT IMPLANTED. WEIGHT AT TIME OF SURGERY WAS (B)(6). NO ISSUES DURING THE SURGERY WERE REPORTED. THIS IS 2 OF 2 REPORT FOR COMPLAINT (B)(4).
ADDITIONAL INFORMATION WAS RECEIVED VIA MEETING MINUTES FROM AN INTERVIEW WITH TWO OF THE PATIENT'S SURGEON'S HELD ON (B)(6), 2014. IT WAS NOTED THAT THE SEQUENCE OF EVENTS DESCRIBED IN THE INTERVIEW IS DIFFERENT FROM THE INFORMATION INITIALLY SUBMITTED TO THE FDA. THEREFORE, CLARIFICATION OF EVENTS IS BEING SUBMITTED WITH THIS FOLLOW UP REPORT. IT WAS REPORTED THAT THE PATIENT HAD BEEN EXTUBATED DURING THE ACTIVE DISTRACTION PHASE BETWEEN (B)(6), 2012, DATE OF INITIAL INTUBATION UNKNOWN. APPROXIMATELY FOUR WEEKS AFTER THE COMPLETION OF THE DISTRACTION PHASE, THE INFANT HAD A RESPIRATORY ARREST EVENT. AS A RESULT, THE PATIENT WAS EMERGENTLY INTUBATED AND A TONGUE LIP ADHESION WAS PERFORMED. IT IS UNKNOWN WHEN THE PATIENT WAS EXTUBATED A SECOND TIME. APPROXIMATELY ONE WEEK AFTER THE TONGUE LIP ADHESION, THE SURGEON SUSPECTED THAT THERE WAS A PROBLEM WITH THE DISTRACTOR. AN X-RAY ON (B)(6), 2013 IDENTIFIED THE COLLAPSE OF THE DISTRACTORS BACK FROM THE PREVIOUSLY ACHIEVED LENGTH. THE SURGEON IMMEDIATELY STARTED RE-DISTRACTING THE PATIENT AT THIS TIME. ON (B)(6), 2013, AN X-RAY REVEALED THE ACHIEVED DISTRACTION AFTER RE-DISTRACTING THE PATIENT FOR ONE WEEK. IT WAS CLARIFIED THAT THERE WAS NO SURGERY PERFORMED ON (B)(6), 2013 AS PREVIOUSLY REPORTED. AS OF (B)(6), 2014, THE PATIENT HAS NOT HAD ANY HARDWARE REPLACED OR BEEN RE-OSTEOTOMIZED DUE TO THE LACK OF BONE OSSIFICATION. THE MEETING MINUTES REVEALED THAT THE SURGEON BELIEVES THE LACK OF OSSIFICATION IS UN-RELATED TO THE DEVICE BECAUSE HE HAS SINCE RE-OPERATED ON THE PATIENT WITH DIFFERENT DEVICES AND HAS NOT BEEN ABLE TO ACHIEVE BONE GROWTH. IT WAS ALSO REPORTED THAT THE PATIENT'S MOTHER HAS SIMILAR MEDICAL ISSUES AND THE PATIENT HAS MULTI-FACTORIAL PROBLEMS. THIS IS 2 OF 2 REPORTS FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 322669 | BC DISTRACTOR BODY END ACT. W/U-JOINT 25MM FOR CMF DSTR | MQN | SYNTHES BRANDYWINE | 6883307 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 MO | Required Intervention |