MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS; GAUGE, DEPTH

Catalog Number	03.130.250
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
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 the distal end of the 1.3mm/1.5mm depth gauge was bent and was asked to be replaced by the surgeon.There was no delay in surgery.The procedure was successfully completed.There was no patient involvement.
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.H11 additional narrative: added: d4 (expiry date), h4.Corrected: d4 (lot, primary udi number).H3, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found the needle was deformed.No other issue was identified.The device was returned inside and opened packaging box with lot: 66825p2 manufactured on 2025.The observed condition of the device was consistent with a component failure that was 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 unable to be performed due to the post-manufacturing damage.A dimensional inspection was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the depth gauge f/scr ø1.3 - 2 meas-range - would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to a component failure, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: dhr of packaging box returned with device: part: 03.130.250-us, lot: 66825p2, manufacturing site: balsthal, release to warehouse: 22-jul-2025.A dhr evaluation was performed for the finished device article#: 03.130.250-us, lot#: 66825p2, and no non-conformance's were identified.Assessment performed by (b)(6).Dhr device returned: part: 03.130.250, lot: 40p8049, manufacturing site: balsthal, release to warehouse: 01-apr-2020.A dhr evaluation was performed for the finished device article#: 03.130.250, lot#: 40p8049, and no non-conformance's 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: DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS
• Common Device Name: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 23359615
• Report Number: 8030965-2025-10611
• Device Sequence Number: 13003049
• Product Code: HTJ
• UDI-Device Identifier: 10886982075420
• UDI-Public: (01)10886982075420(17)411231(10)40P8049
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: 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: 03.130.250
• Device Lot Number: 40P8049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2020
• 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