MAUDE Adverse Event Report: Synthes GmbH 2.0MM RAPID RESORBABLE CORTEX SCREW 4MM-; Plate, Bone

Catalog Number	806.004.02S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction

• Brand Name: 2.0MM RAPID RESORBABLE CORTEX SCREW 4MM-
• Common Device Name: Plate, Bone
• Manufacturer (Section D): Synthes GmbH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): Oberdorf : Synthes Produktions GmbH; eimattstrasse 3; oberdorf CO 80132 ; SZ 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50495440
• Report Number: 8030965-2026-08616
• Device Sequence Number: 10593303
• Product Code: JEY
• UDI-Device Identifier: 20887587061815
• UDI-Public: (01)20887587061815
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• 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: 806.004.02S
• Device Lot Number: 424L708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/05/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2025
• 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 Sex: Unknown