SCALED DRILL Ø2.5MM, AO FITTING
Report
- Report Number
- 0008031020-2014-00255
- Event Type
- Malfunction
- Date Received
- May 30, 2014
- Date of Event
- April 17, 2014
- Report Date
- May 7, 2014
- Manufacturer
- STRYKER TRAUMA SELZACH
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
EVALUATION SUMMARY: BASED ON THE EVENT DESCRIPTION WHICH STATES 2.5MM DRILL BIT WAS BROKEN AS WELL AS THE RECEIVED X-RAY WHICH SHOWS BROKEN DRILL TIPS IN PATIENT BONE THE COMPLAINT HISTORY REVIEW, LABELLING REVIEW, NC/CAPA HISTORY REVIEW AND THE RISK ASSESSMENT WAS PERFORMED ON SCALED DRILL, 2.5MM AO FITTING, REF# 703966 AS THE EVENT HAPPENED DURING A PELVIS II SURGERY AND THE DESCRIPTION STATES A 2.5MM DRILL BIT WAS BROKEN. HOWEVER THE CATALOG NUMBER AND THE LOT CODE WERE NOT PROVIDED, THE REPORTED DEVICE REMAINS UNKNOWN. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. THE OPERATIVE TECHNIQUE PELVIS II SYSTEM OVERVIEW (LITERATURE NUMBER: MT-ST-1 REV 0) WAS REVIEWED AND STATES THE FOLLOWING: "NOTE: INSTRUMENTATION IS PROVIDED TO ASSIST THE SURGEON IN FIXING THE PLATES TO THE BONE AND FOR ACCURATE PLACEMENT OF INDEPENDENT SCREWS. IN ORDER TO ACHIEVE THIS WITHOUT DIFFICULTY, PLEASE ADHERE TO THE FOLLOWING: 1. USE A SHARP DRILL BIT WHEN DRILLING BONE, PARTICULARLY IN AREAS OF HARD, DENSE BONE. ¿ GIVES THE SURGEON MORE CONTROL OF THE DRILL AND HELPS TO PREVENT PLUNGING THAT MAY INJURE NEUROVASCULAR STRUCTURES, VISCERA, OR OTHER SOFT TISSUE STRUCTURES. ¿ LESSENS THE POSSIBILITY OF HEAT BUILD-UP. ¿ BLUNT DRILLS SHOULD BE DISCARDED AND REPLACED WITH NEW ONES. 2. WHEN DRILLING, ESPECIALLY IN PLATES, THE SURGEON SHOULD USE THE DESIGNATED DRILL SLEEVES OR THE NEW PLATE SCREW INSERTER. ¿ THIS ASSURES THE MOST ACCURATE PLACEMENT OF THE SCREW, CENTERED IN THE SCREW HOLE. ¿ THE SLEEVE ACTS AS A GUIDE TO INDICATE THE DIRECTION OF DRILLING. ¿ THE DRILL SLEEVES PROTECT THE ADJACENT SOFT TISSUES. ¿ PREVENTS HEAT BUILDUP AND THE CREATION OF DEBRIS. ¿ PREVENTS THE DRILL FROM BEING SEIZED AND BLOCKED IN THE SLEEVE OR DRILL GUIDE. ¿ PREVENTS DAMAGE TO DRILLS." [ORIGINAL STATEMENT] THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT.
EVALUATION SUMMARY: THE REPORTED EVENT OF THE DRILL BIT BREAKAGE COULD BE CONFIRMED BASED ON THE RECEIVED X-RAY WHICH SHOWS BROKEN DRILL TIPS IN PATIENT BONE. BASED ON THE INVESTIGATION, THE ROOT CAUSE MOST PROBABLY WAS ROTATORY BENDING 20.67 ± 1.03° AND ATTRIBUTED TO A USER RELATED ISSUE. AS THE EVENT HAPPENED DURING AN EPS STUDY ON 17TH APRIL 2014 IT CAN BE ASSUMED THAT THE DRILL WAS NOT MANUFACTURED ACCORDING TO THE LATEST DRAWING REVISION C. MATERIAL CHANGE WAS PERFORMED FOR REVISION C. CHANGE NUMBER KIE14-223 WAS CLOSED ON 26TH AUGUST 2014. REASON/JUSTIFICATION STATED IN KIE14-223: "DURING THIS EPS IT WAS OBSERVED THAT BREAKAGE OF THE DRILLS CAN OCCUR IN SPECIFIC SITUATIONS. ALTHOUGH THE OCCURRENCE RATE IS WELL WITHIN THE ONE DEFINED AND RATED IN THE RISK ANALYSIS, THERE IS POTENTIAL FOR IMPROVEMENT." [ORIGINAL STATEMENT] THE REPORTED COMPLAINT PERTAINS TO CHANGE NUMBER KIE14-223. THE RELATED BML REPORT 14-212 WAS REVIEWED: "BACKGROUND AND PURPOSE: DUE TO CUSTOMERS EXPERIENCE THE MATERIAL OF THE LONG PELVIS II DRILLS WAS CHANGED FROM 1.4112 TO 1.4542 WHICH PROVIDES MORE DUCTILE MATERIAL BEHAVIOR. METHOD: [...] THE ROTATORY BENDING TEST WAS PERFORMED AS A HANDLING TEST USING A POWER TOOL AND CORRESPONDING DRILL SLEEVES. ACCEPTANCE CRITERION: ...] THE ROTATORY BENDING TEST: SUBJECT DEVICE STATISTICALLY EQUAL OR BETTER THEN PREDICATE DEVICE. RESULTS: [...] THE ROTATORY BENDING FAILURE ANGLE WAS FOR ALL MEASUREMENTS 26°. [...] FAILURE ANGLE ROTATORY BENDING MEAN STANDARD DEVIATION MATERIAL 1.4542 26 0 MATERIAL 1.4112 20.67 1.03" [ORIGINAL STATEMENT] THE RISK ANALYSIS S-RA023 REV.7 WAS REVIEWED, THE RISK OF DEBRIS WAS CLASSIFIED AS ACCEPTABLE SEE RISK BENEFIT ANALYSIS AND COMMENT COLUMN: "THE BENEFIT OF THE DEVICES IN QUESTION BY FAR OUTWEIGHS THE RISKS. BREAKAGE OF SURGICAL DEVICES IS A FREQUENT EVENT. IN THE LITERATURE IT IS NAMED APPROX. 0.3 % (O4). MOSTLY THE BROKEN PARTS WOULD BE REMOVABLE WITHOUT ANY GREAT EFFORT. IN SOME CASES THE BROKEN PART WOULD BE POSITIONED INSIDE OF THE BONE OR WOULD BE NOT TRACEABLE IN THE SOFT TISSUE. SMALLER FRAGMENTS WHICH ARE POSITIONED INSIDE OF THE BONE WITHOUT ANY IRRITATION OF THE SURROUNDING TISSUE SHOULD BE LEFT IN PLACE. ALL MATERIALS WHICH ARE USED FOR IMPLANTS (TITANIUM OR STAINLESS STEEL) AND FOR SURGICAL INSTRUMENTS (STAINLESS STEEL) ARE TESTED FOR BIOCOMPATIBILITY. THEREFORE, NO SIGNIFICANT ADVERSE LOCAL OR SYSTEMIC EFFECTS HAVE TO BE EXPECTED IF A SMALL AMOUNT OF DEBRIS FROM DAMAGED IMPLANTS OR INSTRUMENTS WOULD REMAIN IN THE SURGICAL WOUND OR IN THE BONE.[...] DEBRIS OF ORTHOPEDIC IMPLANTS OF AND INSTRUMENTS IS USUALLY ENCAPSULATED BY FIBROUS TISSUE FORMATION AND WILL NOT BE REGISTERED BY THE PATENT. ONLY IN RARE CASES NOTICEABLE SOFT TISSUE IRRITATION MAY RESULT FROM SUCH AN EVENT (S2/O4) OR ADDITIONAL SPECIFIC MEASURES (S2, S3) OR UNINTENDED REVISION SURGERY (S3) WOULD RESULT FROM SUCH AN EVENT." [ORIGINAL STATEMENT] A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED.
IT IS REPORTED BY THE SURGEON THAT THE LONG 2,5MM DRILL TIP BREAKS VERY EASY DURING DRILLING OF THE POSTERIOR INRAPECTINEAL HOLES OF THE PLATE (TWO BREAKAGES IN THIS OPERATION). THE DRILL TIPS COULD BE SEEN IN THE POSTERIOR COLUMN OF THE X-RAY.
IT IS REPORTED BY THE SURGEON THAT THE LONG 2,5MM DRILL TIP BREAKS VERY EASY DURING DRILLING OF THE POSTERIOR INRAPECTINEAL HOLES OF THE PLATE (TWO BREAKAGES IN THIS OPERATION). THE DRILL TIPS COULD BE SEEN IN THE POSTERIOR COLUMN OF THE X-RAY.
IT IS REPORTED BY THE SURGEON THAT THE LONG 2,5MM DRILL TIP BREAKS VERY EASY DURING DRILLING OF THE POSTERIOR INRAPECTINEAL HOLES OF THE PLATE (TWO BREAKAGES IN THIS OPERATION). THE DRILL TIPS COULD BE SEEN IN THE POSTERIOR COLUMN OF THE X-RAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319197 | SCALED DRILL Ø2.5MM, AO FITTING | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | STRYKER TRAUMA SELZACH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |