MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 HYBRID UNITI GLENOID M 26.5; SHOULDER IMPLANT - SHOULDER GLENOID

Catalog Number	510026522
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during a shoulder repair surgery, upon opening the inhance glenoid it was found that the clear plastic inserter tip was disengaged/disconnected from the glenoid.The nurse tried to re-connect this inserter tip to glenoid, but the clips would not grab or hold properly to the peripheral lip of the glenoid.This made it difficult to inert/implant the glenoid into the patient.Surgery was completed successfully with no delay.There were no patient consequences.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Product description: hybrid uniti glenoid m 26.5; product code: 510026522; lot no: mi150365; quantity of manufactured: (b)(4); date of manufacturing: 02-jan-2024; expiry date: 31-dec-2028.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: product description: hybrid uniti glenoid m 26.5; product code: 510026522; lot no: mi150365; quantity of manufactured: (b)(4); date of manufacturing:- 02-jan-2024; expiry date: 31-dec-2028.Device history review: a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: HYBRID UNITI GLENOID M 26.5
• Common Device Name: SHOULDER IMPLANT - SHOULDER GLENOID
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): RESTORATION MEDICAL POLYMERS; 4474 e. park 30 dr; columbia city IN 46725
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20311778
• Report Number: 1818910-2024-20247
• Device Sequence Number: 12933204
• Product Code: HSD
• UDI-Device Identifier: 10603295549154
• UDI-Public: (01)10603295549154(17)281231(10)MI150365
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K212933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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: 510026522
• Device Lot Number: MI150365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown