MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T8 FULL THREAD, 2.7MM/L18MM; SCREW, FIXATION, BONE

Model Number	656418
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported : "screw head broken.Obvious defect.Material consequences: time lost + material lost.For the patient: real level of seriousness." additional information: "a screw broke when tightened with the screwdriver supplied with the screws.The threaded part remained in the patient's bone, and an additional screw was positioned in an adjacent hole in the plate.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the screw is broken as complained.The device inspection revealed the following: a broken off screw head was returned for investigation.The visual inspection has shown that the screw head is broken off at the crossover from the shaft to the head.The visible discoloration in the area of the fracture is an indication for the plastic deformation that occurred before the breakage did happen.There is a strong stress mark at the bottom side of the screw head visible, this mark shows that there was an excessive contact between the head and the plate.In the t8 recess are deformations in clockwise direction visible, these damages are a clear indication for a high load application with the screwdriver.The microscopic evaluation did show that the fracture face has the typical view of an ductile overload fracture, where first a permanent distortion of the material occurs till the device finally breaks.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 a used related issue.The event was caused by an mechanical overload by overtightening the screw.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported : "screw head broken.Obvious defect.Material consequences: time lost + material lost.For the patient: real level of seriousness." additional information: "a screw broke when tightened with the screwdriver supplied with the screws.The threaded part remained in the patient's bone, and an additional screw was positioned in an adjacent hole in the plate.".

• Brand Name: BONE SCREW, T8 FULL THREAD, 2.7MM/L18MM
• Common Device Name: SCREW, 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17236373
• Report Number: 0008031020-2023-00250
• Device Sequence Number: 12201052
• Product Code: HWC
• UDI-Device Identifier: 07613327068955
• UDI-Public: 07613327068955
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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: 656418
• Device Catalogue Number: 656418
• Device Lot Number: 1000322357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown