MAUDE Adverse Event Report: STRYKER GMBH CANNULATED LOW COMPRESSION SCREW AUTOFIX Ø2.0 X 28MM; SCREW, FIXATION, BONE

Model Number	141-2028
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/15/2023
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
As reported: "was in a dip fusion case today and had a 2.0x28mm screw snap right at the start of the distal threads as it was being inserted.Breakage occurred with the screw 99% of the way inserted and we were only able to remove the proximal piece.The rest of the screw remained implanted.Surgeon left the broken screw in the patient's finger and used a cerclage wire to compress the joint.Rep mentioned that the patient will require another surgery down the line to remove the wires.".
Event or Problem Description
As reported: "was in a dip fusion case today and had a 2.0x28mm screw snap right at the start of the distal threads as it was being inserted.Breakage occurred with the screw 99% of the way inserted and we were only able to remove the proximal piece.The rest of the screw remained implanted.Surgeon left the broken screw in the patient's finger and used a cerclage wire to compress the joint.Rep mentioned that the patient will require another surgery down the line to remove the wires.".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned and matches the alleged failure.Device inspection revealed the following: the received cannulated low compression screw is broken from the distal end from the initial start of the threaded portion which confirms the event from the microscopic view we can confirm that the breakage is due to ductile overload as we can clearly see deformation in the clockwise direction before the breakage.The breakage surface has a twisted appearance which points towards ductile breakage with permanent distortion and subsequent fracture.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 the investigation, the root cause can be attributed to user-related.If any additional information is provided, the investigation will be reassessed.

• Brand Name: CANNULATED LOW COMPRESSION SCREW AUTOFIX Ø2.0 X 28MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17304796
• Report Number: 0008031020-2023-00275
• Device Sequence Number: 7213461
• Product Code: HWC
• UDI-Device Identifier: 03700586900851
• UDI-Public: 03700586900851
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K052576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 141-2028
• Device Catalogue Number: 1412028
• Device Lot Number: SB164
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2010
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male