MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T8 FULL THREAD, 2.7MM/L12MM; SCREW, FIXATION, BONE

Model Number	656412
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the event occurs in an osteosynthesis of the left distal radius.At the moment when the specialist decided to fix the branch of the plate with a 2.7 mm cortical screw, the head of the screw fractured despite the fact that all the technique correctly (2.0 mm drill with guide, measurer and screw with t8 screwdriver) the specialist was putting the screw and when giving the last turn with the screwdriver without any overload of force the screw fractured leaving the head of the screw stuck to the blade of the screwdriver and all of its stem inside the patient, the specialist decided to leave that screw and fix the plate with two other 2.7 mm screws, one locking and one cortical that work correctly.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text : device remains implanted in patient.
Additional Manufacturer Narrative
The reported event could be confirmed, from the picture provided which shows the screw head only as the rest screw is still implanted.The device was not returned for investigation, but a picture was provided which confirms the breakage of screw head.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
As reported: "the event occurs in an osteosynthesis of the left distal radius.At the moment when the specialist decided to fix the branch of the plate with a 2.7 mm cortical screw, the head of the screw fractured despite the fact that all the technique correctly (2.0 mm drill with guide, measurer and screw with t8 screwdriver) the specialist was putting the screw and when giving the last turn with the screwdriver without any overload of force the screw fractured leaving the head of the screw stuck to the blade of the screwdriver and all of its stem inside the patient, the specialist decided to leave that screw and fix the plate with two other 2.7 mm screws, one locking and one cortical that work correctly.".

• Brand Name: BONE SCREW, T8 FULL THREAD, 2.7MM/L12MM
• 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: 16944732
• Report Number: 0008031020-2023-00200
• Device Sequence Number: 6356141
• Product Code: HWC
• UDI-Device Identifier: 07613327068887
• UDI-Public: 07613327068887
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• 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: 656412
• Device Catalogue Number: 656412
• Device Lot Number: 1000487332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2022
• 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: Female