MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 INHANCE; SHOULDER INSTRUMENT - DRIVER

Catalog Number	650510103
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned device does not found stripped that the star driver 20.However, has tip broken and signs of slight usage on its overall surface.Broken piece was not returned for evaluation and no additional damage was identified on its surface.Potential cause can be traced to an off-axis assembly, over torquing, actuating the device before it was fully seated or by applying excessive force during the assembly/disassembly process.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.As per inhance¿ shoulder system ¿ surgical technique, the following precautions need to be followed: 1) using the driver handle and star driver 20, thread the peripheral screw into place until it is fully seated in the baseplate; 2) peripheral screws must be fully seated within the baseplate manually using the star driver 20 and the driver handle; and 3) only the locking & self-drilling screws do not require a pilot drill using the peripheral screw drill.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 star driver 20 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 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 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.
Event or Problem Description
It was reported that after the case and decontamination, the sets were put back together and inspected.It was noticed that the t20 was stripped.This happened post op so there was no negative impact to the patient nor was surgery time extended due to this.

• Brand Name: INHANCE
• Common Device Name: SHOULDER INSTRUMENT - DRIVER
• 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: 25175602
• Report Number: 1818910-2026-08805
• Device Sequence Number: 10567364
• Product Code: HWR
• UDI-Device Identifier: 10603295547631
• UDI-Public: (01)10603295547631(10)213747
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• 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: 650510103
• Device Lot Number: 213747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• 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