MAUDE Adverse Event Report: DePuy Ireland - 3015516266 INHANCE; Shoulder Instrument - Insertion Device

Catalog Number	650011104
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # = >(b)(4) investigation summary = > according to the information provided, "it was reported that baseplate inserter rod with not thread on the glenosphere inserter tip." the product was returned to depuy synthes for evaluation, and an investigation was conducted in accordance with depuy synthes procedures.Visual analysis of the glenosphere inserter tip found the thread cavity and the distal tip stripped.Additionally, the device displays an overall condition consistent with constant usage in a clinical setting over time.A functional test was performed with a mating device and difficulty during the assembling process was noted, most likely due to the damage observed at the thread cavity.The observed condition can be attributed to unintended use error, which may have resulted from exposure to unintended forces, such as overtightening, off¿axis assembly, and heavy usage.Proper handling and adherence to the approved use of the device can diminish the risk of failure.As per the surgical technique, the following precautions need to be followed while assembling and disassembling the device with its mating component: ¿to place the definitive glenosphere, assemble the glenosphere inserter tip to the baseplate inserter rod.Next, thread the inserter tip into the selected glenosphere until it is snug.Care should be taken not to overtighten.Navigate the glenosphere taper into the baseplate and impact the baseplate inserter rod to seat the glenosphere.¿ additionally, ¿prior to removing the glenosphere inserter tip, twist and pull to ensure that the taper is fully seated.Please note that if the glenosphere inserter tip is left behind when unthreading the baseplate inserter rod, the star driver 30 can be utilized to remove the inserter tip.¿ the reported complaint was confirmed based on the evaluation results.The investigation traced the potential cause to unintended use error.It has been determined that no corrective or preventive actions are proposed.There is no indication that a design or manufacturing issue caused the reported condition.As part of depuy synthes quality processes, all devices are manufactured, inspected, and released in accordance with approved specifications.Additional monitoring for potential safety signals is conducted through complaint trend analysis as part of post-market safety surveillance activities.Device history review = > 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: d3 (manufacturer email), h3.

• Brand Name: INHANCE
• Common Device Name: Shoulder Instrument - Insertion 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: 50548573
• Report Number: 1818910-2026-14956
• Device Sequence Number: 16099262
• Product Code: LXH
• UDI-Device Identifier: 10603295547266
• UDI-Public: (01)10603295547266(10)217580
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 650011104
• Device Lot Number: 217580
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/11/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2023
• 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