MAUDE Adverse Event Report: SYNTHES GMBH MULTILOC END CAP F/MULTILOC HN/PHN EXTEN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.019.005S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
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.Additional narrative: 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) 2026, the patient underwent orif surgery with multiloc for proximal humerus fractures.The surgeon selected a 5mm end cap, but it became stuck midway through the insertion procedure.The surgeon tried inserting the end cap again, this time paying attention to its orientation, but still had difficulty completing it.The end cap was removed and checked, and the threads were found to be undamaged with no apparent defects.The surgeon made sure there were no obstructions such as bones, cleaned the end cap, and tried the insertion again, but it was unsuccessful.The surgeon gave up on using the 5mm end cap, and a 2mm end cap was inserted.However, it had become embedded, and the surgeon was concerned that the anchoring effect could not be achieved and changed it to a 10mm end cap, but it had protruded from the joint surface.One last attempt was made to insert the 5mm end cap, and it was successful.The surgery was completed successfully within 30 minutes' delay.No further information is available.
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.H11 additional narrative: corrected: g1.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Investigation summary.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 number: 04.019.005s.Lot number: 32595p0.Manufacturing site: mezzovico.Release to warehouse date: 25 sep 2024.Expiration date: 01 sep 2034.A manufacturing record evaluation was performed for the sterile finished lot number, and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MULTILOC END CAP F/MULTILOC HN/PHN EXTEN
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico CO ; SZ
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24188920
• Report Number: 8030965-2026-00922
• Device Sequence Number: 9766897
• Product Code: HSB
• UDI-Device Identifier: 10886982089571
• UDI-Public: (01)10886982089571(17)340901(10)32595P0
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• 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: 04.019.005S
• Device Lot Number: 32595P0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2024
• 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