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

Catalog Number	620510101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
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 returned to depuy synthes for evaluation.Visual analysis of the impactor handle revealed the threaded tip broken.Additionally, the device exhibits an overall worn appearance consistent with normal and constant usage.It is worth mentioning that the tip was not returned for evaluation.The observed condition of the device is consistent with a random component failure, which may have resulted from exposure to unintended forces, such as overtightening, off-axis impactions, and heavy usage.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 impactor handle 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: 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 impactor handle's threaded part broke off, and the white impactor tip cracked.There was no patient involvement or impact, as the event occurred during set-up or cleaning.

• Brand Name: INHANCE
• Common Device Name: SHOULDER INSTRUMENT - IMPACTOR HANDLE
• 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: 24915631
• Report Number: 1818910-2026-07082
• Device Sequence Number: 9827779
• Product Code: LXH
• UDI-Device Identifier: 10603295539384
• UDI-Public: (01)10603295539384(10)200497
• Combination Product (Y/N): N
• 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,Company Representative
• 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: 620510101
• Device Lot Number: 200497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2022
• 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