MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI CORTEX SCREW SELF-TAPPING 24MM; SCREW, FIXATION, BONE

Catalog Number	404.824
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent internal fixation surgery on (b)(6) 2023 due to distal humeral fracture.One month later, the patient came to the hospital for reexamination, and it was found that a total of four screws were broken.It is unknown whether the patient underwent a second surgery.Patient status is unknown.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.H3, h4, h6: product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot : part:404.824.Lot no: l309552.Release to warehouse date: 08 feb, 2017.Manufacturing site: werk grenchen.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received states that after investigation, the patient was a 51-year-old male who underwent "internal fixation of distal humerus fracture" on (b)(6) 2023 due to "distal humerus fracture".The surgical process went smoothly.The patient's postoperative rehabilitation was unknown.One month after the surgery, it was found by ct examination that 4 screws in the internal fixation of the patient were broken (whether the patient had fall, impact, strenuous exercise, etc.Before the occurrence of the event was unknown, and the specific product code of the broken screws were unknown).The patient was in a stable condition currently.The hospital did not provide further details about the event and the patient's subsequent treatment.

• Brand Name: 3.5MM TI CORTEX SCREW SELF-TAPPING 24MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 21116497
• Report Number: 8030965-2025-00347
• Device Sequence Number: 7436874
• Product Code: HWC
• UDI-Device Identifier: 10886982207340
• UDI-Public: (01)10886982207340(10)L309552
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K131186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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 Catalogue Number: 404.824
• Device Lot Number: L309552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2017
• 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 Age: 51 YR
• Patient Sex: Male