MAUDE Adverse Event Report: Synthes GmbH DEPTH PROBE; GAUGE, DEPTH

Catalog Number	03.122.052
Medical Device Problem Codes	Device Slipped (1584); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, the patient underwent orif surgery on the upper arm.During surgery, the tip of the probe detached.Although it could be reattached, it became loose, so a different product was used.There was no impact on the patient.The surgery was completed successfully without any surgical delay.After the surgery, the product was returned to distribution center with a note attached indicating "instrument damage.".
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.Additional narrative: h6: 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 wire of the length probe for 03.122.053 + 03.122.058 was detached from the body as a result of a broken weld.All components were received with the returned sample, and no other issues were observed during the evaluation.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 dimensional inspection for the length probe f/03.122.053+03.122.058 was not performed due to post manufacturing damage.A functional test was not performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the length probe f/03.122.053+03.122.058 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.Device history review: part: 03.122.052.Lot: 49p1297.Manufacturing site: hägendorf.Release to warehouse: 24-april-2020.A dhr evaluation was performed for the finished device article 03.122.052 lot 49p1297, and no non-conformances were identified.

• Brand Name: DEPTH PROBE
• Common Device Name: GAUGE, DEPTH
• Manufacturer (Section D): Synthes GmbH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): Werk Hägendorf (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50858467
• Report Number: 8030965-2026-09653
• Device Sequence Number: 9936749
• Product Code: HTJ
• UDI-Device Identifier: 07611819394476
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: Exempt
• 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

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: 03.122.052
• Device Lot Number: 49P1297
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2020
• 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