MAUDE Adverse Event Report: SYNTHES GMBH DHS®/DCS® LAG SCREW 12.7MM THREAD/110MM-STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	280.100S
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
Event or Problem Description
It was reported that there was an issue with the lag screw.The surgeon described it as not feeling quite right when screwing it in but wondered it just due to the good bone quality, they then tried to fit the dhs plate over the screw and it wouldn¿t fit, they took the screw out and the top where they insert the screw driver looked warped.They replaced the screw with a new one and it worked fine.

• Brand Name: DHS®/DCS® LAG SCREW 12.7MM THREAD/110MM-STERILE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): Werk Balsthal (CH); dornacherstrasse 20; balsthal CO 80132 ; SZ 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 25240560
• Report Number: 8030965-2026-04798
• Device Sequence Number: 13417597
• Product Code: KTT
• UDI-Device Identifier: 10886982174925
• UDI-Public: (01)10886982174925(17)360201(10)98308P1
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K791619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,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: 280.100S
• Device Lot Number: 98308P1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Supplement Date Received by Manufacturer: 05/26/2026; 08/03/2026; 08/06/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 05/29/2026; 08/04/2026; 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2026
• 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