MAUDE Adverse Event Report: 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 12MM; SCREW, FIXATION, BONE

Model Number	02.214.112
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2021, during an unknown plate implantation, heads of the there (3) 1.5mm cortex screws snapped off during insertion.The broken screw heads were removed.In removing the screw shafts, one of the shafts broke a second time.Surgeon had to use the screw removal set to remove the broken fragments of the screws.All fragments were removed successfully with an unspecified amount of a surgical delay.The surgery was completed successfully.This report is for one (1) 1.5mm cortex screw slf-tpng with t4 stardrive recess 12mm this is report 2 of 3 for complaint (b)(4).
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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.

• Brand Name: 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 12MM
• Common Device Name: SCREW, FIXATION, BONE
• MDR Report Key: 12754493
• Report Number: 2939274-2021-06510
• Device Sequence Number: 14682567
• Product Code: HWC
• UDI-Device Identifier: 10886982055460
• UDI-Public: (01)10886982055460
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2021

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: 02.214.112
• Device Catalogue Number: 02.214.112
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 11/04/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK - PLATES: TRAUMA