MAUDE Adverse Event Report: DePuy Ireland - 3015516266 INHANCE; Alignment Device

Catalog Number	620010001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the version indicator instrument was broken by sterile processing department staff while being removed from the stem inserter for cleaning.The incident did not occur during surgery or in the operating room.All available information has been disclosed.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11.Additional manufacturer narrative: h3, h6: 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.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection revealed one prong broken from the version indicator.Device had signs of usage on its overall surface and the broken portion was not returned for evaluation.No other anomaly was identified on the device surface.The observed damage can be traced to an unintended use error by usage of excessive force in a prying motion or by trialing with the device in a misaligned or off-axis position.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.As per inhance¿ shoulder system ¿ surgical technique ,the next precautions need to be followed: 1) place the version indicator on the side of the mating component (humeral stem pin punch/stem inserter), which matches the patient¿s operative side and, with slight pressure, clicking it onto the top of the mating device; 2) adjust the version indicator as indicated for each mating component assembly, where a side-to-side movement is needed for the humeral stem pin punch assembly; and a rotation movement, for the stem inserter, considering the version indicator about the axis of the inserter until the desired version has been selected.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 version indicator 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.

• Brand Name: INHANCE
• Common Device Name: Alignment Device
• Manufacturer (Section D): DePuy Ireland - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50713262
• Report Number: 1818910-2026-15416
• Device Sequence Number: 9779103
• Product Code: HWT
• UDI-Device Identifier: 10603295538967
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 620010001
• Device Lot Number: 318384
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 75 YR
• Patient Sex: Male