MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE; GAUGE, DEPTH

Catalog Number	351.717
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that on (b)(6) 2024, a box of the basic instruments of the tn advanced were not sent.The patient was already under anesthesia.
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.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Investigation summary : information has been reviewed and determined that there is no allegation of deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of the j&j medtech orthopaedics device after it was released for distribution.However, a deliver service issue (dsi) is indicated and addressed internally within a local quality management system.Device history lot : the device lot number is unknown, therefore a device history review could not be performed.If more information become available, the record will be re-assessed.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.H3, h6: visual analysis of the photo showed the advanced nail base tray for opening and insertion instruments with all the instruments in place within the brackets except the direct measuring device which was laid across the top of the tray.No product issues were identified in the photo.It was determined that there was a delivery issue with the set which will be addressed internally within the local quality management system.The complaint was confirmed based on the delivery information.There is no indication of a design or manufacturing issue and additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review : the device lot number is unknown, therefore a device history review could not be performed.If more information become available, the record will be re-assessed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: DEPTH GAUGE
• Common Device Name: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20439789
• Report Number: 8030965-2024-12791
• Device Sequence Number: 15555124
• Product Code: HTJ
• UDI-Device Identifier: 07611819739185
• UDI-Public: (01)07611819739185
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 351.717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 10/21/2024; 11/08/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 10/23/2024; 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown