MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE F/SCR Ø4.5 - 6.5 MEAS-RANGE; GAUGE, DEPTH

Catalog Number	319.100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
J&j medtech is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which j&j medtech has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, j&j medtech or its employees that the report constitutes an admission that the device, j&j medtech, 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.Additional narrative: investigation summary photos were provided for review.The photographs attached were reviewed, however in the images provided no observations pertaining to the nature of the reported event could be identified.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the nut component was not returned within the device.Additionally, the needle end and shaft were deformed.The reported condition can be confirmed.However, with available evidence a complete potential cause for this condition can not be determined.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test 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 ø4.5 - 6.5 meas-range would have contributed to the complained device issue.Based on the investigation findings, 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 j&j medtech orthopaedics 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.Dimensional inspection: n/a device history a manufacturing record evaluation was performed for the finished device product code: 319.100 lot number: 39p7847 it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 06 feb 2020 manufacturing site: jabil bettlach a manufacturing record evaluation was performed for the finished device 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 an instrument was found to be missing a component on return inspection.The product damage documented during loan kit inspection, by the loan kit technician.The event date and alert date are the date that the inspection took place.There is no surgeon, procedure, or patient details available.No further information can be obtained as the case was not reported by the customer.¿.

• Brand Name: DEPTH GAUGE F/SCR Ø4.5 - 6.5 MEAS-RANGE
• Common Device Name: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): JABIL BETTLACH; muracherstrasse 3; bettlach ; SZ
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22177268
• Report Number: 8030965-2025-05800
• Device Sequence Number: 7818606
• Product Code: HTJ
• UDI-Device Identifier: 10886982190017
• UDI-Public: (01)10886982190017(10)39P7847
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• 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: 319.100
• Device Lot Number: 39P7847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2020
• 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