MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 DEPTH GAUGE; SHOULDER INSTRUMENT - DEPTH GAUGE

Catalog Number	650010101
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when kitting the instrument set, the product in question was found to be bent upon opening.The product in question has not been shipped.No further information is available.The product was returned from the hospital.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint recon described in this report.H11 additional narrative: added: d9.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary it was reported that when kitting the instrument set, the product in question was found to be bent upon opening.The product in question has not been shipped.No further information is available.The product was returned from the hospital.The product was returned to depuy synthes for evaluation.Visual inspection found that the depth gauge was returned deformed in the middle section.No other anomalies were noted.The observed condition is consistent with excessive force applied during the assembling/disassembling process that overload the device material; or by an off-axis assembly before it was fully seated.Properly handling and attention to the approved use of the device diminishes the risk of failure.As per inhance¿ shoulder system reverse surgical technique with kickstand¿ augment surgical technique addendum, page 34 "place the baseplate into the prepared glenoid over the glenoid pin, taking care to orient the peripheral holes where desired to achieve the best fixation (figure 97).A general starting point is to orient one peripheral screw hole directly inferior which places the other peripheral holes superior anterior near the base of the coracoid and superior posterior.When the desired orientation is achieved, impact the baseplate into place.After the baseplate is fully seated, use the baseplate inserter handle to provide counter-torque and unthread the baseplate inserter rod".A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection 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 would have contributed to the complained issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is required.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes 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 lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Corrected: h3.

• Brand Name: DEPTH GAUGE
• Common Device Name: SHOULDER INSTRUMENT - DEPTH GAUGE
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23348091
• Report Number: 1818910-2025-17880
• Device Sequence Number: 21197668
• Product Code: HTJ
• UDI-Device Identifier: 10603295547242
• UDI-Public: (01)10603295547242(10)180910
• 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,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: 650010101
• Device Lot Number: 180910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 11/04/2025; 12/08/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 11/05/2025; 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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