MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW T8, 2.7MM / L42MM; SCREW, FIXATION, BONE

Catalog Number	656442
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "screw head broke off during final tightening" update 29-jan-2024: the surgical delay was 5-10 minutes.The entire screw was removed from the surgical field.Update 31-jan-2024: there was hard bone.
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: the screw is broken apart as complained, the breakage occurred at the crossover from the shaft to the head, all fragments were returned for evaluation.The t8 recess has strong deformations in clockwise direction, which indicates that the head was exposed to high forces during implantation.The fracture face has at the screw head the typical view of a ductile overload fracture, where the applied force is first causing permanent distortion of the material, indicated by the discoloration around the fracture, with a subsequent breakage.The permanent distortion of the material, indicated by the discoloration below the fracture face, is also visible at the shaft.The thread flanks are strongly damaged at the top and at the bottom, in retrospective it cannot be defined if these damages were caused during insertion or the extraction after the head broke off.However, the rest of the thread flanks is also damaged, which indicates that there was an excessive metallic contact of the thread, e.G.With the plate, another screw or guide wire, during the insertion of the screw.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 a mechanical overload during the insertion of the screw.Most likely was the overload caused by a combination of the reported hard bone and a metallic contact.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "screw head broke off during final tightening" update-29-jan-2024 ¿the surgical delay was 5-10 minutes.¿the entire screw was removed from the surgical field.Update-31-jan-2024 there was hard bone.

• Brand Name: BONE SCREW T8, 2.7MM / L42MM
• 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: 18704675
• Report Number: 0008031020-2024-00093
• Device Sequence Number: 12611511
• Product Code: HWC
• UDI-Device Identifier: 07613327462555
• UDI-Public: 07613327462555
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K191412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

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: 656442
• Device Lot Number: 1000526211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2023
• 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