MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 GLENOSPHERE 40+8; SHOULDER IMPLANT - GLENOSPHERE

Catalog Number	550540008
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: according to the information received, ¿it was reported that the 20 star driver tip broke off while inserting metaglene could not retrieve and lodged into set screw head.Ended up pulling metaglene implant off while in the process inserter tip cold welded into glenosphere.Had to implant new glenosphere.No surgical delay.¿ the device associated with this report was returned to depuy synthes for evaluation.Visual examination of the device confirmed that the glenosphere extractor tip is jammed inside the glenosphere 40+8.Additionally, the inner threads of the glenosphere appear to be stripped and a small fragment of the taper has broken off most likely due to extraction process.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces such as excessive force or off axis threading of the device.The overall complaint was confirmed as the observed condition of the glenosphere 40+8 would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to unintended use error and 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 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.H6: component code: appropriate term/code not available (g07002) used to capture no findings available.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.
Event or Problem Description
It was reported that the 20 star driver tip broke off while inserting metaglene could not retrieve and lodged into set screw head.Ended up pulling metaglene implant off while in the process inserter tip cold welded into glenosphere.Had to implant new glenosphere.No surgical delay.

• Brand Name: GLENOSPHERE 40+8
• Common Device Name: SHOULDER IMPLANT - GLENOSPHERE
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17652537
• Report Number: 1818910-2023-17892
• Device Sequence Number: 6314264
• Product Code: PHX
• UDI-Device Identifier: 10603295547174
• UDI-Public: 10603295547174
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K212737
• 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
• Report Date (Section B): 08/30/2023

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: 550540008
• Device Lot Number: 333397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male