MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 BASEPLATE INSERTER HANDLE; SHOULDER INSTRUMENT - INSERTION DEVICE

Catalog Number	650011101
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
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 report, a follow-up report will be filed as appropriate.H11 additional manufacturer narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that during a reverse total shoulder arthroplasty, performed by the surgeon on (b)(6) 2025, at the hospital the enhance baseplate inserter rod and baseplate inserter handle became fused to the baseplate implant during implantation.The surgeon was unable to disengage the construct from the implant, so entire construct was removed from patient, and new implant and backup instruments were used to complete the case.There was a surgical delay of two (2) minutes.No fragments were generated.The procedure was completed successfully and there were no patient consequences.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "during a reverse total shoulder arthroplasty, performed by the surgeon on (b)(6) 2025 at the hospital the inhance baseplate inserter rod (product code 6500-11-102, lot (01)10603295547235) and baseplate inserter handle (product number 6500-11-101, lot (01)10603295547228) became fused to the baseplate implant during implantation.Surgeon was unable to disengage the construct from the implant, so entire construct was removed from patient, and new implant and backup instruments were used to complete the case".The product was not returned to medtech orthopaedics , however photos were provided for review.See attachment (img_7322.Jpeg).The device associated with this report was not returned to medtech orthopaedics ; for evaluation.The photographs attached were reviewed, however the provided evidence was not sufficient to confirm the reported event of jammed/seized.Functionality issues cannot be evaluated through a photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the observed condition of the baseplate inserter rod would not contribute 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 complaint condition.As part of medtech orthopedics 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 lot: the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: BASEPLATE INSERTER HANDLE
• 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 ; 9083863534
• MDR Report Key: 22296484
• Report Number: 1818910-2025-10164
• Device Sequence Number: 8282245
• Product Code: LXH
• UDI-Device Identifier: 10603295547228
• UDI-Public: (01)10603295547228
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,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: 650011101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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