SCREWDRIVER BIT T15, AO FITTING
Report
- Report Number
- 0008031020-2017-00583
- Event Type
- Malfunction
- Date Received
- October 6, 2017
- Date of Event
- September 12, 2017
- Report Date
- March 2, 2018
- Manufacturer
- STRYKER GMBH
- Product Code
- HWC
- PMA / PMN Number
- K133440
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
THE REPORTED FAILURE MODE COULD BE CONFIRMED BY THE INSPECTION OF THE RETURNED DEVICES. THE DHR ARE WAS REVIEWED AND NO ABNORMALITIES WERE FOUND. THEREFORE, THE SCREWDRIVERS WERE ACCORDING TO SPECIFICATIONS. EXPLANT OF SCREWS IS TYPICALLY MORE DIFFICULT THAN THE INSERTION OF SCREWS. THE PATIENT IS A YOUNG MAN. THE EXPLANATION WAS DONE A YEAR AFTER THE IMPLANTATION BY THE SAME SURGEON. IT IS POSSIBLE THAT BONE BUILDS UP A STRONG ADHERENCE TO THE SCREWS DURING ONE YEAR. THIS MAY HAVE LED TO THE DIFFICULTIES DURING THE EXPLANATION. FROM THE DEVICE INSPECTION, THE SIGNIFICANT ORTHOGONAL FRACTURE ALONG THE SURFACE OF THE DEVICE, WHICH IS VERY ROUGH, INDICATES THAT A VERY HIGH TORQUE WAS APPLIED INSTANTANEOUSLY TO FREE THE SCREW FROM THE STATIC FRICTION / ADHESION. THE ROOT CAUSE IS MOST LIKELY THE APPLICATION OF HIGH TORQUE. FURTHERMORE, FROM THE PROVIDED IMAGES, IT CAN BE SEEN THAT NO TORQUE LIMITER WAS USED.
IT WAS REPORTED BY PRODUCT SPECIALIST THAT AT THE CLINIC (B)(6), A SURGERY WAS PERFORMED BY DR. (B)(6) (FIRST OPERATOR) AND DR. (B)(6) (SECOND OPERATOR) AN AXSOS 3 PLAQUE REMOVAL ACTION ON A YOUNG MAN PATIENT: A PROXIMAL MEDIAL TIBIAL PLAQUE AND A PROXIMAL LATERAL TIBIAL PLAQUE. PLATE IMPLANTATION WAS PERFORMED BY THE SAME SURGEONS A YEAR AGO. REMOVAL SURGERY (BEFORE THE LATERAL PLATE, THEN THE MEDIAL ONE) LASTED ABOUT 90 MINUTES LONGER SINCE THERE HAVE BEEN SOME PROBLEMS. THE TIP OF THE SINGLE KEYLESS T15 SCREWDRIVER (CODE 1806-6119, LOT K152426) BROKE RIGHT AWAY, NOT JUST DR (B)(6). WAS TRYING TO REMOVE A SCREW LOCK FROM THE SIDE PLATE; PRECISELY THAT THE SURGEON, EVEN BEFORE USING THE SCREWDRIVER, HE POINTED OUT THAT THE TIP WAS SLIGHTLY CROOKED, DEFECTIVE PROBABLY DUE TO WEAR. SINCE THERE WERE NO OTHER T15 SCREWDRIVERS AT THE CLINIC, WE STERILIZED THE INSTRUMENT EUK-AXS3-4MM-PLTTI-1., AFTER STERILIZATION, USING THE EUK-AXS3-4MM-PLTTI-1, THEY WERE ABLE TO REMOVE BOTH PLATES BUT WITH SOME DIFFICULTY: TWO T15 SCREWDRIVERS WERE BROKEN.
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
IT WAS REPORTED BY PRODUCT SPECIALIST THAT AT THE CLINIC (B)(6), A SURGERY WAS PERFORMED BY DR. (B)(6) (FIRST OPERATOR) AND DR. (B)(6) (SECOND OPERATOR) AN AXSOS 3 PLAQUE REMOVAL ACTION ON A YOUNG MAN PATIENT: A PROXIMAL MEDIAL TIBIAL PLAQUE AND A PROXIMAL LATERAL TIBIAL PLAQUE. PLATE IMPLANTATION WAS PERFORMED BY THE SAME SURGEONS A YEAR AGO. REMOVAL SURGERY (BEFORE THE LATERAL PLATE, THEN THE MEDIAL ONE) LASTED ABOUT 90 MINUTES LONGER SINCE THERE HAVE BEEN SOME PROBLEMS. THE TIP OF THE SINGLE KEYLESS T15 SCREWDRIVER (CODE 1806-6119, LOT K152426) BROKE RIGHT AWAY, NOT JUST DR (B)(6). WAS TRYING TO REMOVE A SCREW LOCK FROM THE SIDE PLATE; PRECISELY THAT THE SURGEON, EVEN BEFORE USING THE SCREWDRIVER, HE POINTED OUT THAT THE TIP WAS SLIGHTLY CROOKED, DEFECTIVE PROBABLY DUE TO WEAR. SINCE THERE WERE NO OTHER T15 SCREWDRIVERS AT THE CLINIC, WE STERILIZED THE INSTRUMENT (B)(4), AFTER STERILIZATION, USING THE (B)(4), THEY WERE ABLE TO REMOVE BOTH PLATES BUT WITH SOME DIFFICULTY: TWO T15 SCREWDRIVERS WERE BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 705195 | SCREWDRIVER BIT T15, AO FITTING | SCREW, FIXATION, BONE | HWC | STRYKER GMBH | K0D5B99 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |