MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE F/SCR Ø1.3+1.5 SST

Catalog Number	319.004
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent osteosynthesis for the distal end of the radial & ulnar fractures.The surgery was completed successfully with no surgical delay.The event did not impact surgery the j&j¿s distributor found that the tip of the depth gauge was broken when delivery to the hospital.The depth gauge was not used in the surgery.This event didn¿t affect the surgery.
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.Investigation summary: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the needle was broken off.Broken fragment was retuned for analysis.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces.Additionally, the condition of the device upon newly receipt remains unknown; device was manufactured 9 years ago.The surface of the device also exhibits severe damage by scratches consistent with repetitive use wear.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was not performed since it was not applicable to the complaint condition.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 ø1.3+1.5 sst 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 part # 319.004, synthes lot # h032431, supplier lot# h032431, release to warehouse date: 13 july 2016, supplier: (b)(4), no ncrs were generated during production.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 F/SCR Ø1.3+1.5 SST
• Common Device Name: DEPTH GAUGE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• 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: 22505811
• Report Number: 8030965-2025-07124
• Device Sequence Number: 15639860
• Product Code: HTJ
• UDI-Device Identifier: 10886982189936
• UDI-Public: (01)10886982189936(10)H032431
• 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: 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: 319.004
• Device Lot Number: H032431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2016
• 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