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

Catalog Number	620510103
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
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.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.Investigation summary the product was returned to depuy synthes for evaluation.Visual analysis of the returned device found that the concave impactor tip was broken and cracked around the threaded area.The broken fragment was not returned for evaluation.The radel concave impactor tip fractured through the threads at interface of the distal flat where the mating metal impaction handle threads into.The location of the fracture in combination with observed thread damage and crack propagation in the threaded region of the impactor tip suggests brittle overload from uneven distribution of load during impaction.On the basis of these observations, the potential cause is traced to unintended use error due to uneven force applied during impaction.No material or manufacturing defects were observed that could have contributed to the observed fracture.A dimensional inspection and functional testing were not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the concave impactor tip would have contributed to a 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 the glenosphere inserter tip threads stripped t-handle modular glenoind base plate and glenoshere inserter threads stripped.Additionally, 2x star 20 screw drivers were stripped.All devices are intact.No delays as the reporter have backup.No harm to patient or staff.

• Brand Name: INHANCE
• Common Device Name: SHOULDER INSTRUMENT - IMPACTOR TIP
• 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: 25714923
• Report Number: 1818910-2026-11397
• Device Sequence Number: 14726053
• Product Code: HWA
• UDI-Device Identifier: 10603295539407
• UDI-Public: (01)10603295539407(10)175362
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 620510103
• Device Lot Number: 175362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2021
• 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: 74 YR
• Patient Sex: Male