MAUDE Adverse Event Report: SYNTHES PRODUKTIONS GMBH 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 22; SCREW, FIXATION, BONE

Model Number	201.772
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional product code: hrs.Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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, the patient underwent a surgical procedure.During the surgery, surgeon attempted to put cortex screw through the guide block on a two column distal radius plate.But the stardrive cortex screw heads do not fit through the guide block.The procedure was completed successfully with a surgical delay of 1-2 minutes.There was no patient consequence.Concomitant device reported: unknown 2.4mm two column distal radius plate (part# unknown; lot# unknown; quantity: 1) this complaint involves three(3) devices.This report is for (1) 2.4 cortex screw slf-tpng t8 sd rec 22 this report is 3 of 3 for (b)(4).

• Brand Name: 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 22
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES PRODUKTIONS GMBH; dornacherstrasse 20; balsthal 4710 ; SZ 4710
• MDR Report Key: 12337818
• Report Number: 8030965-2021-06782
• Device Sequence Number: 2696063
• Product Code: HWC
• UDI-Device Identifier: 10886982142795
• UDI-Public: (01)10886982142795
• Combination Product (Y/N): N
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2021

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: 201.772
• Device Catalogue Number: 201.772
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/18/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 22; UNK - GUIDES/SLEEVES/AIMING: GUIDE