MAUDE Adverse Event Report: 4.5 CANNULATED SCREW FULLY THREADED/42; SCREW, FIXATION, BONE

Model Number	214.742
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2021, a 4.5 mm cannulated screw broke at the tip of the screw when the surgeon was placing screw-in patients distal humerus.The surgeon had drilled approximately half of the total screw with a 3.2mm drill bit before placing the screw.It was stated that the surgeon did not want to retrieve fragments.There was a surgical delay of three (3) minutes.The procedure successfully completed.No patient consequence.This report is for one (1) 4.5 cannulated screw fully threaded/42.This is report 1 of 1 for (b)(4).

• Brand Name: 4.5 CANNULATED SCREW FULLY THREADED/42
• Common Device Name: SCREW, FIXATION, BONE
• MDR Report Key: 12700031
• Report Number: 2939274-2021-06311
• Device Sequence Number: 19202413
• Product Code: HWC
• UDI-Device Identifier: 10886982154422
• UDI-Public: 10886982154422
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2021

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: 214.742
• Device Catalogue Number: 214.742
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention