MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER AXSOS T15 4.0MM LOCKING SET; PLATE, FIXATION, BONE

Catalog Number	702747
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
A doctor wrote a letter, in which she said : "stryker screwdrivers should be declared in material vigilance for axsos equipment.Both the handle screwdrivers and the ao quick-release screwdrivers break when removing some screws that are too tight and it is impossible to remove the screws without destroying the screw head.A patient from (b)(6) was entrusted to me for an equipment removal, the surgeon had broken the only axsos screwdriver he had.When i removed this patient's equipment, i broke 2 screwdrivers myself about a month ago.For this last intervention yesterday, i broke 3 screwdrivers of the same brand for the same type of material device.The fact of having destroyed the screw heads to remove the material lengthens the operating time so the risk of infection becomes major, multiple metallic foreign bodies are scattered, while with stronger screwdrivers there would be no particular problem" additional information reported: "the breakage of these unstable screwdrivers seems to us to occur during the removal of the titanium torx screws, even though they were installed with a torque screwdriver.Note that there is no breakage during installation, but when removing material, both the screwdrivers on the handle and the quick ao snap-on bits.This happened on the other side of (b)(6) and the surgeon who only had a stryker screwdriver could not continue the procedure, the patient was entrusted to us remotely to finish removing the screws and plate and we had the same problem and had to resolve to destroy by metal wick the two screw heads still healthy and unscrewable.When this problem happened again at a few weeks' intervals, knowing that we had had quite a few broken screwdrivers, i asked for a statement.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: both tips of the returned screwdriver blades are indeed completely broken / snapped off.The entire drive (on both screwdrivers) is broken off which clearly indicates that exceptional force had been used during this screw removal attempt.Further investigations using the microscope revealed some torsion lines (cracks) which can be clearly noticed, whereas the high applied forces led to a strain hardening / embrittlement of the material which finally resulted in the breakage.The root cause of the failure was repeated powerful dynamically overload during use especially when removing screws.Unfortunately no further detailed informations were available.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to be user related.The failure was caused by exceptional force which had been applied during screw removal.If any further information is provided, the investigation report will be updated.
Event or Problem Description
A doctor wrote a letter, in which she said : "stryker screwdrivers should be declared in material vigilance for axsos equipment.Both the handle screwdrivers and the ao quick-release screwdrivers break when removing some screws that are too tight and it is impossible to remove the screws without destroying the screw head.-a patient from northern france was entrusted to me for an equipment removal, the surgeon had broken the only axsos screwdriver he had.-when i removed this patient's equipment, i broke 2 screwdrivers myself about a month ago.-for this last intervention yesterday, [.] i broke 3 screwdrivers of the same brand for the same type of material device.The fact of having destroyed the screw heads to remove the material lengthens the operating time so the risk of infection becomes major, multiple metallic foreign bodies are scattered, while with stronger screwdrivers there would be no particular problem" additional information reported: "the breakage of these unstable screwdrivers seems to us to occur during the removal of the titanium torx screws, even though they were installed with a torque screwdriver.Note that there is no breakage during installation, but when removing material, both the screwdrivers on the handle and the quick ao snap-on bits.This happened on the other side of france.And the surgeon who only had a stryker screwdriver could not continue the procedure, the patient was entrusted to us remotely to finish removing the screws and plate and we had the same problem and had to resolve to destroy by metal wick the two screw heads still healthy and unscrewable.When this problem happened again at a few weeks' intervals, knowing that we had had quite a few broken screwdrivers, i asked for a statement.".

• Brand Name: SCREWDRIVER AXSOS T15 4.0MM LOCKING SET
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9397805
• Report Number: 0008031020-2019-02022
• Device Sequence Number: 13986533
• Product Code: HRS
• UDI-Device Identifier: 07613327005011
• UDI-Public: 07613327005011
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 702747
• Device Lot Number: Y45398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1