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	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
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.Additional narrative: h6: photo investigation: the product was not returned to j&j medtech orthopaedics, however photos were provided for review.The photo investigation revealed that the depth gauge f/volt scrs ø2.4/2.7 meas-ra is outside of its original packaging and has a bent tip.There is no further evidence to attribute this condition to a manufacturing issue.It is reasonable to conclude that the damage may have occurred during transportation or storage.The overall complaint was confirmed as the observed condition of the depth gauge f/volt scrs ø2.4/2.7 meas-ra 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.H3, h6: product investigation summary: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the the needle tip was bent.No other issue was observed.The reported condition can be confirmed, however, with available evidence, it remains unknown the state of the device upon newly receipt.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces.However, the complete potential cause remains undetermined.Consideration must be given to all other potential influences such as manipulation, transport and/or storage.A dimensional inspection was unable to be performed due to the post-manufacturing damage.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 depth gauge f/volt scrs ø2.4/2.7 meas-ra 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.H3, h4, h6: device history record (dhr) review conducted: 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.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 that product listed below was received damaged in original packaging.During manufacturing investigation of the returned device it was identified that the needle tip was bent.

• 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 wrights lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 21963654
• Report Number: 8030965-2025-04561
• Device Sequence Number: 17918406
• Product Code: HTJ
• UDI-Device Identifier: 10886982335937
• UDI-Public: (01)10886982335937(10)J017071
• Combination Product (Y/N): N
• 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

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: 04/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 05/05/2025
• 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