HEXAGON SCREWDRIVER SHORT 3,5 MM PART 1
Report
- Report Number
- 3012523063-2025-00052
- Event Type
- Malfunction
- Date Received
- May 26, 2025
- Date of Event
- April 26, 2025
- Report Date
- August 1, 2025
- Manufacturer
- IMPLANTCAST GMBH
- Product Code
- HXX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
IT WAS REPORTED TO THE IMPLANT CAST GMBH THAT A PATIENT WITH A MUTARS® GENUX® MK KNEE PROSTHESIS HAD TO BE REVISED AFTER AN IMPLANTATION PERIOD OF 1 YEAR AND 8 MONTHS DUE TO A PERIPROSTHETIC INFECTION. THE MUTARS® DIST. FEMUR M-O-M, THE COUPLING, THE SCREW FOR COUPLING AND THE SAFETY SCREW WERE EXCHANGED. DURING THE REVISION SURGERY THE SCREW FOR COUPLING WAS DIFFICULT TO REMOVE. THE TIP OF THE USED HEXAGON SCREWDRIVER SHORT 3,5 MM PART 1 FRACTURED. HOWEVER, A SECOND SCREWDRIVER WAS AVAILABLE, AND THE SURGERY COULD BE FINISHED SUCCESSFULLY. THEREFORE, THERE WAS NO HEALTH EFFECT ON THE PATIENT. THE SCREWDRIVER WAS RETURNED TO IMPLANTCAST AND WAS SUBJECT TO THE OPTICAL EXAMINATION. THE TIP OF THE SCREWDRIVER BROKE OFF DIAGONAL TO THE SHAFT. THE MANUFACTURING DOCUMENTS OF THE SCREWDRIVER WERE CHECKED. THESE DID NOT REVEAL ANY ERRORS. THE SURGICAL TECHNIQUES AND INSTRUCTIONS FOR USE WERE CHECKED AND SHOWED NO DEVIATIONS. THE FRACTURE OF THE SCREWDRIVER CAN BE REGARDED AS A CONSEQUENTIAL ERROR OF THE STUCK SCREW FOR COUPLING. WHY EXACTLY THE SCREW FOR COUPLING WAS STUCK INSIDE THE TIBIA CAN ONLY BE ASSUMED. AS THE PATIENT IS QUITE YOUNG (23 YEARS OLD) AND SPORTY, THIS MAY HAS LED TO STRESS ON THE JOINT, INCREASING THE RISK FOR COMPLICATIONS. MAYBE AN UNUSUAL LOAD ON THE COUPLING SCREW HAS LED TO A SLIGHT DEFORMATION. ANOTHER POTENTIAL REASON COULD BE TISSUE REMNANTS ATTACHED TO THE THREAD OF THE SCREW. HOWEVER, THERE IS NO INFORMATION AVAILABLE TO SUPPORT THESE HYPOTHESES. THIS EVENT WAS ASSIGNED TO THE ERROR PATTERN "BREAK OF THE INSTRUMENT" IN THE ASSOCIATED RISK MANAGEMENT.
IT WAS REPORTED TO THE IMPLANTCAST GMBH THAT A PATIENT WITH A MUTARS® GENUX® MK KNEE PROSTHESIS HAD TO BE REVISED AFTER AN IMPLANTATION PERIOD OF 1 YEAR AND 8 MONTHS DUE TO A PERIPROSTHETIC INFECTION. THE MUTARS® DIST. FEMUR M-O-M, THE COUPLING, THE SCREW FOR COUPLING AND THE SAFETY SCREW WERE EXCHANGED. DURING THE REVISION SURGERY THE SCREW FOR COUPLING WAS DIFFICULT TO REMOVE. THE TIP OF THE USED HEXAGON SCREWDRIVER SHORT 3,5 MM PART 1 FRACTURED. HOWEVER, A SECOND SCREWDRIVER WAS AVAILABLE, AND THE SURGERY COULD BE FINISHED SUCCESSFULLY. THEREFORE, THERE WAS NO HEALTH EFFECT ON THE PATIENT. OPTICAL EXAMINATION OF THE EXPLANTS WAS NOT POSSIBLE, AS THEY WERE NOT PROVIDED TO THE IMPLANTCAST GMBH. THE SCREWDRIVER WAS RETURNED TO IMPLANTCAST AND WAS SUBJECT TO THE OPTICAL EXAMINATION. THE TIP OF THE SCREWDRIVER BROKE OFF DIAGONAL TO THE SHAFT. THE MANUFACTURING DOCUMENTS AND DESCRIPTION OF THE SURGICAL TECHNIQUE WERE CHECKED, NO DEVIATIONS WERE FOUND. STERILISATION CERTIFICATES CONFIRM THAT THE IMPLANTS WERE DELIVERED STERILE. THEREFORE, A CAUSAL RELATIONSHIP BETWEEN THE INFECTION AND THE IMPLANTS CAN BE EXCLUDED. THE INCIDENT WAS ASSIGNED TO THE HAZARD I "MICROBIAL CONTAMINATION, INFECTION" IN THE ASSOCIATED RISK MANAGEMENT OVERVIEW. THE INSTRUCTION FOR USE EXPLAINS THAT THE DURABILITY OF AN IMPLANT CAN BE LIMITED BY BIOLOGICAL, MATERIAL, AND BIOMECHANICAL FACTORS. AS THE PATIENT IS QUITE YOUNG (23 YEARS OLD) AND SPORTY, THIS MAY HAS LED TO STRESS ON THE JOINT, INCREASING THE RISK FOR COMPLICATIONS. MAYBE AN UNUSUAL LOAD ON THE COUPLING SCREW HAS LED TO A SLIGHT DEFORMATION, WHICH CAUSES SLUGGISHNESS. ANOTHER POTENTIAL REASON COULD BE TISSUE REMNANTS ATTACHED TO THE THREAD OF THE SCREW. HOWEVER, THERE IS NO INFORMATION AVAILABLE TO SUPPORT THESE HYPOTHESES. ULTIMATELY, THE SCREW COULD BE SUCCESSFULLY REMOVED. THE INCIDENT WAS ASSIGNED TO THE HAZARD "INCOMPATIBILITY" IN THE ASSOCIATED RISK MANAGEMENT OVERVIEW. BASED ON THE AVAILABLE INFORMATION, IT WAS NOT POSSIBLE TO DETERMINE A TECHNICAL ROOT CAUSE FOR THE SCREWDRIVER BREAKAGE. THEREFORE, IT IS ASSUMED THAT THE MALFUNCTION OCCURRED AS A RANDOM FAILURE. IT IS POSSIBLE THAT THE SCREWDRIVER WAS SLIGHTLY DAMAGED BY PREVIOUS USE, AS IT IS A REUSABLE INSTRUMENT. ANOTHER POTENTIAL CAUSE COULD BE AN UNINTENTIONAL USER ERROR. HOWEVER, THERE IS NO INFORMATION AVAILABLE TO SUPPORT THESE HYPOTHESES. THE MANUFACTURING DOCUMENTS OF THE SCREWDRIVER WERE CHECKED. THESE DID NOT REVEAL ANY ERRORS. THE SURGICAL TECHNIQUES AND INSTRUCTIONS FOR USE WERE CHECKED AND SHOWED NO DEVIATIONS. THIS EVENT WAS ASSIGNED TO THE ERROR PATTERN "BREAK OF THE INSTRUMENT" IN THE ASSOCIATED RISK MANAGEMENT.
THE FOLLOWING EVENT WAS REPORTED TO IMPLANT CAST GMBH: "WHEN PERFORMING A DAIR PROCEDURE, (B)(6) WENT TO THE MOVE THE TIBIAL COUPLING SCREW CAP AND THAT WAS REMOVED WITH EASE, HOWEVER WHEN (B)(6) WENT TO REMOVE THE MAIN SCREW, IT APPEARED TO HAVE BONDED WITH THE TIBIA THREAD MAKING IT INCREDIBLY HARD TO REMOVE. WHEN FORCE WAS THEN APPLIED THE SCREW DRIVER TIP SHEARED OFF COMPLETELY. WE HAD A SPARE SCREW DRIVER WITHIN THE HOSPITAL SO WE WERE ABLE TO GAIN ACCESS TO ANOTHER BUT IF THIS WASN'T POSSIBLE WE WOULD HAVE MOST DEFINITELY HAD TO HAVE ABANDONED THE CASE. "
THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "WHEN PERFORMING A DAIR PROCEDURE, MR (B)(6) WENT TO THE MOVE THE TIBIAL COUPLING SCREW CAP AND THAT WAS REMOVED WITH EASE, HOWEVER WHEN MR (B)(6) WENT TO REMOVE THE MAIN SCREW, IT APPEARED TO HAVE BONDED WITH THE TIBIA THREAD MAKING IT INCREDIBLY HARD TO REMOVE. WHEN FORCE WAS THEN APPLIED THE SCREWDRIVER TIP SHEARED OFF COMPLETELY. WE HAD A SPARE SCREWDRIVER WITHIN THE HOSPITAL SO WE WERE ABLE TO GAIN ACCESS TO ANOTHER BUT IF THIS WASN'T POSSIBLE, WE WOULD HAVE MOST DEFINITELY HAD TO HAVE ABANDONED THE CASE. " FURTHER INFORMATION WAS PROVIDED: "THE ONLY IMPLANTS THAT WERE REMOVED WERE THE COUPLING SCREW, THE COUPLING, AND THE DISTAL FEMUR AND UNFORTUNATELY, THEY HAVE BEEN DISPOSED OF NOW." THIS EVENT WAS SPLIT TO COVER ALL ERROR PATTERNS WITH THEIR RESPECTIVE MAIN COMPONENTS: (B)(6) : THE INFECTION (DAIR PROCEDURE) WITH THE DISTAL FEMUR AS MAIN COMPONENT. (B)(6) : THE INCOMPATIBILITY (STUCK SCREW) OF THE SCREW INSIDE THE TIBIA WITH THE SCREW FOR COUPLING AS MAIN COMPONENT. (B)(6) : THE BROKEN OFF TIP OFF THE SCREWDRIVER WITH THE HEXAGON SCREWDRIVER AS MAIN COMPONENT. NOTE: ONLY THE INCIDENT (B)(6) WAS CONSIDERED AS REPORTABLE TO THE FDA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 326372 | HEXAGON SCREWDRIVER SHORT 3,5 MM PART 1 | SCREWDRIVER | HXX | IMPLANTCAST GMBH | 02801007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Male | Other | MUTARS® COUPLING 12.5 MM TINBN| MUTARS® COUPLING 12.5 MM TINBN| MUTARS® DIST. FEMUR M-O-M 110 MM LEFT SILVER INCL.| MUTARS® DIST. FEMUR M-O-M 110 MM LEFT SILVER INCL.| MUTARS® DISTAL FEMUR M-O-M SILVER 110MM LEFT| MUTARS® DISTAL FEMUR M-O-M SILVER 110MM LEFT| MUTARS® EPORE® HA COLLAR 20 MM OVAL 30 / 33 MM| MUTARS® EPORE® HA COLLAR 20 MM OVAL 30 / 33 MM| MUTARS® GENUX® MK MB PE INSERT SZ. 5 / 12.5 MM| MUTARS® GENUX® MK MB PE INSERT SZ. 5 / 12.5 MM| MUTARS® GENUX® MK OFFSET ADAPTER 2 MM| MUTARS® GENUX® MK OFFSET ADAPTER 2 MM| MUTARS® GENUX® MK STEM CEMENTLESS 14 / 150 MM HA| MUTARS® GENUX® MK STEM CEMENTLESS 14 / 150 MM HA| MUTARS® GENUX® MK TIBIA CEMENTED SZ. 5 TIN| MUTARS® GENUX® MK TIBIA CEMENTED SZ. 5 TIN| MUTARS® GENUX® MK TIBIA CEMENTED SZ. 5 TIN INCL. S| MUTARS® GENUX® MK TIBIA CEMENTED SZ. 5 TIN INCL. S| MUTARS® SCREW FOR COUPLING| MUTARS® SCREW FOR COUPLING| MUTARS® SCREW M10 X 45 MM| MUTARS® SCREW M10 X 45 MM| MUTARS® STEM CEMENTED MODULAR CURVED 13 / 160 MM| MUTARS® STEM CEMENTED MODULAR CURVED 13 / 160 MM| SAFETY SCREW| SAFETY SCREW |