MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE FOR MULTILOC HUMERAL NAILING SYSTEM

Catalog Number	03.019.017
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
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: h6: photo investigation: the photographs provided were reviewed, however the provided evidence was not sufficient to confirm the reported event of "fell apart - unattached" h3, h6: product investigation summary: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the needle of the depth gauge f/multiloc hum nail syst was unattached from body as the weld that joins these components was broken.All components were received for investigation.A dimensional inspection for the depth gauge f/multiloc hum nail syst was not performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Properly handling and attention to the approved use of the device diminishes the risk of failure.A functional test was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the depth gauge f/multiloc hum nail syst would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.There is no indication that a design or manufacturing issue has caused the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H3, h4, h6: device history record (dhr) review conducted: part number: 03.019.017 lot number: 57p8879 manufacturing site: hägendorf release to warehouse date: 26.08.2020 a manufacturing record evaluation was performed for the finished device batch 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.
Event or Problem Description
It was reported that on (b)(6) 2026, the patient underwent an orif surgery for proximal humerus fracture on humerus with the product in question.In the surgery, a multiloc short screw (8mm diameter) was used.The operation proceeded smoothly until the first distal lateral fixation step was completed, at which point the incident occurred.After drilling, the surgeon measured with the depth gauge in question and then removed it.The thin tip of the depth gauge separated from the base of the main body (the part with the markings) and remained in the drilled hole.It was removed with a kocher screwdriver, and the second distal screw was measured using the drill bit.The operation was completed without further issues.The surgery was completed successfully with no surgical delay.The depth gauge was not handled roughly, but it seemed to have come off without any apparent sensation.No further information is available.

• Brand Name: DEPTH GAUGE FOR MULTILOC HUMERAL NAILING SYSTEM
• Common Device Name: DEPTH GAUGE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: elba bello ; 1302 wrights lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 25095319
• Report Number: 8030965-2026-04310
• Device Sequence Number: 9959695
• Product Code: HTJ
• UDI-Device Identifier: 07611819427174
• UDI-Public: (01)07611819427174(10)57P8879
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 03.019.017
• Device Lot Number: 57P8879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown