HALLU- FIX ABLATION SET
Report
- Report Number
- 9615741-2018-00081
- Event Type
- Injury
- Date Received
- June 5, 2018
- Report Date
- April 30, 2018
- Manufacturer
- NEWDEAL SAS
- Product Code
- HWC
- PMA / PMN Number
- K990622
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- DENTAL HYGIENIST
Narratives
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
PRODUCT ID UPDATED. INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION: AS PRODUCTS ARE NOT RETURNED, NO FAILURE ANALYSIS WAS PERFORMED. AS NO PRODUCT ID AND NO MANUFACTURING LOT NUMBER WAS PROVIDED, NO DHR, DESIGN SPECIFICATION OR DESIGN CHANGE RECORD WILL BE PERFORMED. A REVIEW OF THE CURRENT ¿INSTRUCTION FOR USE ND 00131 (NON-STERILE) AND ND 01831(STERILE)¿ WAS PERFORMED. AS WE CAN SEE IN PARAGRAPH ¿PRECAUTIONS FOR USE¿, THAT ¿BONE NON-UNION OR DELAYED UNION¿, ARE MENTIONED AS FREQUENT ADVERSE EVENTS THAT COULD LEAD INTO RE-OPERATION, REVISION OR REMOVAL SURGERY, ARTHRODESIS OF THE INVOLVED JOINT, AND /OR AMPUTATION OF THE LIMB. IN CONCLUSION: FREQUENT ADVERSE EVENTS ARE MENTIONED IN IFU. AS DHR REVIEW AND FAILURE ANALYSIS COULD NOT BE PERFORMED, ROOT CAUSE CANNOT BE DETERMINED.
THE JOURNAL OF FOOT AND ANKLE SURGERY (2012) PUBLISHED: "ARTHRODESIS OF THE FIRST METATARSOPHALANGEAL JOINT: A RETROSPECTIVE ANALYSIS OF PLATE VERSUS SCREW FIXATION." THE PURPOSE OF THIS STUDY WAS TO IDENTIFY THE BEST FIXATION CONSTRUCT IN REGARD TO FUSION RATES AND RADIOLOGIC NONUNION. THIS IS A RETROSPECTIVE ANALYSIS PERFORMED FROM JANUARY 2000 TO APRIL 2010. SEVENTY-TWO PROCEDURES WERE PERFORMED IN 69 PATIENTS: 48 FEMALES AND 21 MALES. THEIR MEDIAN AGE WAS 62 (RANGE 36 TO 84). YEARS. THESE PATIENTS HAD UNDERGONE SURGERY ON 41 RIGHT AND 31 LEFT FEET; 3 PATIENTS HAD RECEIVED BILATERAL PROCEDURES. BECAUSE DIFFERENT FIXATION TECHNIQUES WERE USED, THESE PATIENTS WERE DIVIDED INTO 4 SUBGROUPS: (1) SINGLE 2.7-MM CANNULATED, SELF-TAPPING LAG SCREW FIXATION (BOLD SCREW, INTEGRA LIFE SCIENCES, (B)(4); N ¼ 24), (2) CROSSED 2.7-MM, CANNULATED, SELF-TAPPING LAG SCREW FIXATION (N ¼ 21), (3) PRECONTOURED TITANIUM ALLOY, LOW-PROFILE, NONLOCKING PLATE (HALLUFIX S-PLATE SYSTEM, INTEGRA LIFE SCIENCES) FIXATION (N ¼ 13), AND (4) PRECONTOURED, TITANIUM ALLOY, LOW-PROFILE, NONLOCKING PLATE (HALLUFIX S-PLATE SYSTEM, INTEGRA LIFE SCIENCES) COMBINED WITH PLANTAR, 2.7-MM, CANNULATED, SELF-TAPPING LAG SCREW FIXATION (N ¼ 14). THE PLATES WERE FIXED USING THE STANDARD 2.7-MM SNAP OFF SCREWS SUPPLIED WITH THE PLATE. THE 24 PATIENTS WITH SINGLE SCREW FIXATION HAD A MEDIAN AGE OF 60 (RANGE 38 TO 84) YEARS, AND 15 WERE FEMALE AND 9 MALE. THEY UNDERWENT SURGERY ON 14 RIGHT AND 10 LEFT FEET. THE 21 PATIENTS WITH CROSSED SCREW FIXATION HAD A MEDIAN AGE OF 58 (RANGE 43 TO 78) YEARS, AND 15 WERE FEMALE AND 6 MALE. THEY UNDERWENT SURGERY ON 13 RIGHT AND 8 LEFT FEET. THE MTPJ-1 ARTHRODESES PERFORMED WITH SINGLE SCREW FIXATION HAD A FUSION RATE OF 71%, WITH 17 OF 24 FUSED. THOSE FIXED USING CROSSED SCREWS HAD A FUSION RATE OF 90%, WITH 19 OF 21 FUSED. EVENTS: NINE NONUNIONS WITH BOLD CREWS: 7 WITH SINGLE SCREW AND 2 WITH CROSSED SCREW. TEN DELAYED FUSIONS: 5 WITH SINGLE SCREW AND 5 WITH CROSSED SCREW. RESULT: THE STATISTICAL ANALYSIS OF THE 4 DIFFERENT SUBGROUPS REGARDING FUSION AT 6 WEEKS AND 3 MONTHS AFTER SURGERY SHOWED NO STATISTICALLY SIGNIFICANT DIFFERENCES. AN ANALYSIS OF THE NONUNIONS SHOWED THAT PLATE FIXATION ALONE RESULTED IN A SIGNIFICANTLY LOWER RATE OF NONUNION THAN DID SINGLE SCREW FIXATION (P ¼ .038). WE FOUND NO SIGNIFICANT DIFFERENCE IN THE RESULTS FOR THE OTHER FIXATION TECHNIQUES REGARDING THE RATE OF NONUNION. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO THE AUTHOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 412912 | HALLU- FIX ABLATION SET | HALLU-FIX | HWC | NEWDEAL SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |