MAUDE Adverse Event Report: SYNTHES GMBH 2.4/2.7 VOLT(TM) DEPTH GAUGE/ 0 TO 90MM; GAUGE, DEPTH

Catalog Number	03.424.090
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 2.4/2.7 volt(tm) depth gauge/ 0 to 90mm was found in sterile processing department to have the plastic piece broken and flaking plastic pieces off.
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.H11 additional manufacturer narrative: h3, h6: part: 03.424.090.Synthes lot: j017071.Supplier lot: j017071.Release to warehouse date: 07 jun,2024.Supplier: (b)(4).No ncrs generated during production review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Photo investigation: photos were provided for review.The photo investigation revealed that 2.4/2.7 volt(tm) depth gauge/ 0 to 90mm (03.424.090) had broken.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the 2.4/2.7 volt(tm) depth gauge/ 0 to 90mm would contribute to the complaint about the device issue.Based on the investigation findings, potential cause can be attributed to 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 complaint condition.As part of 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.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: h3, h4, h6 the product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned sample revealed that the 2.4/2.7 volt(tm) depth gauge/ 0 to 90mm was broken at the endo of the plastic slider.The broken fragment was still attached to the needle.The fracture surface was examined, and no damage related to manufacture was observed.In addition the needle was slightly bent.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces a dimensional inspection was not performed since it was not applicable to the complaint condition a functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the 2.4/2.7 volt(tm) depth gauge/ 0 to 90mm 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.Device history review: part: 03.424.090.Synthes lot: j017071.Supplier lot: (b)(4).Release to warehouse date: 07 jun 2024.Supplier: (b)(4).No ncrs generated during production dhr is retrieved from (b)(4).Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: the product was not returned to medtech orthopaedics, however photos were provided for review.The photo investigation revealed that 2.4/2.7 volt(tm) depth gauge/ 0 to 90mm (03.424.090) had broken.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the 2.4/2.7 volt(tm) depth gauge/ 0 to 90mm would contribute to the complaint about the device issue.Based on the investigation findings, potential cause can be attributed to 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 complaint condition.As part of 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.Device history review part: 03.424.090 synthes lot: j017071 supplier lot: j017071 release to warehouse date: 07 jun,2024 supplier: vivant medical no ncrs generated during production dhr is retrieved from pi-(b)(4).Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.4/2.7 VOLT(TM) DEPTH GAUGE/ 0 TO 90MM
• Common Device Name: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): BRIDGEWATER DISTRIBUTION; 50 scotland boulevard; bridgewater MA 02324
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22458691
• Report Number: 8030965-2025-06883
• Device Sequence Number: 18292048
• Product Code: HTJ
• UDI-Device Identifier: 10886982335937
• UDI-Public: (01)10886982335937(10)J017071
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,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: 03.424.090
• Device Lot Number: J017071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/22/2025
• Supplement Date Received by Manufacturer: 07/18/2025; 07/22/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 07/21/2025; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• 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