MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BLADE T8 AO, SELF RETAINING; PLATE, FIXATION, BONE

Model Number	703663
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "during the me, the screwdriver blade (703663 variax2 sd blade t8) broke when the screw was unscrewed.Replacement was available".
Additional Manufacturer Narrative
The reported event could be confirmed, since the tip of the screwdriver is broken off.The device inspection revealed the following: the visual inspection has shown that the tip of the screwdriver is broken off, no fragments returned for evaluation.The remainder of the tip is twisted in counter-clockwise direction.This indicates that during the loosening of a screw a plastic deformation occurred due to high torsional force.The microscopic evaluation has shown that the view of the fracture face is typical for a brittle overload fracture with chevron marks and a shear lip on one side.The shear lip indicates that the device was exposed to high lateral forces when it broke.Based on these findings it can be concluded that a combination of high torsional and lateral forces during the screw extraction did lead to a mechanical overload.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.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.Based on investigation, the root cause was finally attributed to a user related issue.The failure was caused by applying too much torsional and lateral force which did lead to a mechanical overload during the extraction of a screw.In this relation following statement of the implant extraction set operative technique can be mentioned: the development of locking plate technology has led to ¿cold welding¿ of screws to the plates.In this case, cutting tools for metal have to be used for the removal of the screws.In order to help protect the soft tissue from excessive heat and metal debris accumulation, irrigation and suction should be used in combination with cutting tools.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "during the me, the screwdriver blade (703663 variax2 sd blade t8) broke when the screw was unscrewed.Replacement was available".

• Brand Name: SCREWDRIVER BLADE T8 AO, SELF RETAINING
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13313830
• Report Number: 0008031020-2022-00024
• Device Sequence Number: 1561865
• Product Code: HRS
• UDI-Device Identifier: 07613327069754
• UDI-Public: 07613327069754
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K132502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2022

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 Model Number: 703663
• Device Catalogue Number: 703663
• Device Lot Number: AG07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2021
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male