MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLENOSPHERE ORIENTATION GUIDE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	230795000
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon had chosen to use an eccentric glenosphere so as per surgical technique opted to use the glenosphere guide when screwing on the glenosphere to get the orientation correct.The surgeon had some difficulties with the muscles being quite tight in the area and it proved difficult screwing in the glenosphere.The consultant noticed that the small metal nipple that is on the end of the guide had broken off.The small piece of metal was not visible and at that point it wasn¿t clear whether it had been taken up by the suction or was still inside the patient.The x-ray taken revealed that the metal piece was still inside the patient and had fallen somewhere down the arm into the muscle.The surgeon decided it would cause more damage to retrieve the piece of metal and so decided to leave it inside the patient.X-ray was taken which caused 25-30 minutes of delay to the procedure.The hospital had to open another one of their trays to get an identical instrument to proceed with the procedure.
Additional Manufacturer Narrative
(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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition, therefore it has been determined that no corrective and preventive action is required at this time.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.H.11.Additional narrative: added: b5.
Event or Problem Description
Additional information received states that the event occurred during primary and the patient was left with metal foreign object inside.No adverse consequences reported.

• Brand Name: GLENOSPHERE ORIENTATION GUIDE
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 21945333
• Report Number: 1818910-2025-06867
• Device Sequence Number: 8720341
• Product Code: PHX
• UDI-Device Identifier: 10603295116592
• UDI-Public: (01)10603295116592
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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: 230795000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 09/08/2025
• 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