DYNANAIL NAIL, 10X220MM
Report
- Report Number
- 3007593722-2024-00003
- Event Type
- Injury
- Date Received
- February 27, 2024
- Date of Event
- January 22, 2024
- Report Date
- February 27, 2024
- Manufacturer
- MEDSHAPE, INC.
- Product Code
- JDS
- UDI-DI
- M970120001102202
- PMA / PMN Number
- K113828
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- 003
Narratives
ON 31JAN24, (B)(6), INDEPENDENT SALES REPRESENTATIVE REPORTED A BROKEN DYNANAIL 10X220MM NAIL AT THE DISTAL PORTION OF THE NAIL ABOVE BOTH THE PA AND CORTICAL SCREW. THE NAIL WAS REMOVED ON (B)(6) 2024 (ORIGINALLY IMPLANTED ON (B)(6) 2022) AND REVISED WITH 2 DYNANAIL HELIX NAILS IN ATTEMPT TO FUSE THE SUBTALAR REGION (WHICH DID NOT FUSE FROM THE DYNANAIL). THE REMAINING PORTION AND 2 TIBIAL SCREWS REMAINED IN THE PATIENT'S LEG. IN CONCLUSION, BASED ON EVALUATION OF INFORMATION PROVIDED AND REVIEW OF RISK MATRIX FOR THIS FAILURE, THE MOST PROBABLE ROOT CAUSE CAN BE ATTRIBUTED TO PATIENT REPEAT STRESS LOADING ON NON-FUSED SUBTALAR REGION AS THE NAIL HAD BEEN FUNCTIONING AS A "STATIC" NAIL LIKELY FOR 1+ YEAR AFTER USE OF ALL 6MM OF COMPRESSION. AS THE PATIENT WAS CONSIDERED "MORBIDLY OBESE" AND HAD A DIABETIC CONDITION, LITERATURE HAS DEMONSTRATED THAT THIS PATIENT POPULATION IS AT MUCH HIGHER RISK OF BONE NON-UNION FOLLOWING IMPLANTATION OF FUSION NAILS, SUCH AS DYNANAIL. THE PHOTOS IN FIGURE 1 AND 2 DOCUMENTED NAIL CONDITION DOES NOT SHOW ANYTHING CONCERNING REGARDING THE FRACTURE WHICH WOULD SUGGEST A DEFECT IN THE NAIL OR MATERIAL. WITHOUT UNION OF THE SUBTALAR JOINT, A HIGH MECHANICAL DEMAND IS PLACED ON THE HARDWARE, AND SUCH A FAILURE IS NOT UNEXPECTED IN THIS SUSPECTED FATIGUE LOADING SCENARIO. GENERALLY WITH A NONUNION, THIS IS THE FRACTURE PATTERN / LOCATION THAT SHOULD BE EXPECTED, AS IT OCCURRED AT A LOCATION NEAR WHERE THE NAIL DIAMETER TRANSITIONED FROM A LARGER TO SMALLER SIZE. OF THE 3 POTENTIAL CAUSES LISTED IN ED-50048 RISK MATRIX, DHR REVIEW DOES NOT SUGGEST "MATERIAL FAILURE" TO BE THE CAUSE. THEREFORE, BASED ON INFO PROVIDED LIKELY COMBINATION OF "NON-UNION OF BONE" FOLLOWED BY APPROXIMATELY 1 YEAR OF "EXCESSIVE FORCES PLACED ON NAIL". DESPITE THE BREAKAGE TO THE DYNANAIL, WHICH REQUIRED REMOVAL, DR. SUCCESSFULLY IMPLANTED 2 DYNANAIL HELIX NAILS TO ATTEMPT TO FUSE THE SUBTALAR REGION, WHICH DID NOT FUSE FROM THE DYNANAIL TTC CASE IN (B)(6) 2022. COMMUNICATION ON 14FEB24 INDICATED THAT AS THE REMOVAL HAS OCCURRED THERE ARE NO ADDITIONAL REQUESTS FROM EITHER SALES REPRESENTATIVE OR DR. COMPLAINT HISTORY REVIEW SHOWS 2 DYNANAIL NAILS THAT HAVE HAD THIS FAILURE IN THE LAST YEAR, WHICH REPRESENTS A (B)(4)% FAILURE RATE (2 FAILURES / ~5,000 DYNANAIL SURGERIES IN LAST YEAR). GIVEN THE CAUSE DETERMINATION, EXTREMELY LOW RATE OF OCCURRENCE OF THIS FAILURE MODE, SUCCESSFUL REVISION TO ALTERNATIVELY FUSE THE SUBTALAR REGION AND NO INDICATION OF MANUFACTURING / MATERIAL DEFICIENCY, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. FUTURE SIMILAR COMPLAINTS SHALL BE MONITORED PER QS-8.2.1.1, SOP, COMPLAINTS AND FURTHER ACTIONS MAY BE TAKEN IF NECESSARY.
ON 31JAN24, (B)(6), INDEPENDENT SALES REPRESENTATIVE REPORTED A BROKEN DYNANAIL 10X220MM NAIL AT THE DISTAL PORTION OF THE NAIL ABOVE BOTH THE PA AND CORTICAL SCREW. THE NAIL WAS REMOVED ON (B)(6) 2024 (ORIGINALLY IMPLANTED ON (B)(6) 2022) AND REVISED WITH 2 DYNANAIL HELIX NAILS IN ATTEMPT TO FUSE THE SUBTALAR REGION (WHICH DID NOT FUSE FROM THE DYNANAIL). THE REMAINING PORTION AND 2 TIBIAL SCREWS REMAINED IN THE PATIENT'S LEG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110170 | DYNANAIL NAIL, 10X220MM | NAIL, FIXATION, BONE | JDS | MEDSHAPE, INC. | D0058 | M970120001102202 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male | Other |