MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US STD GLENOSPHERE TRIAL D38MM; EXTREMITY INSTRUMENTS : GLENOSPHERE TRIALS

Catalog Number	230760138
Medical Device Problem Codes	Break (1069); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
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.H11 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.
Event or Problem Description
It was reported that on an unknown date, the glenosphere trial was broken and cleaned with soft and broken plastic.The hospital had damaged trials in all their sets, and they can not guarantee that the trial became sterile after cleaning.The hospital staff commented that it felt as if the plastic on the trials was softer than it used to be.
Event or Problem Description
Additional information received states that there was a surgical delay and all pieces of the broken instrument were retrieved from the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: b3, b5, g1 (manufacturing site name), h6 (health effect - impact code) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary according to the information received, "it is a glenosphere trial [product code removed] 1 it is broken and cleaned with soft and broken plastic." the product was not returned to medtech orthopaedics; however photos were provided for review.See attachment ¿(b)(4) hi_¿, ¿picture1¿ and ¿picture2¿.The photo investigation revealed that '230760138, std glenosphere trial d38mm¿ had broken.However, the reported condition of foreign substance/debris/cleaning/sterilization for device remains unconfirmed.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces.The provided evidence was not sufficient to confirm the reported event of foreign substance/debris/cleaning/sterilization.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the std glenosphere trial d38mm 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 complaint condition.As part of medtech orthopaedics 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 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.

• Brand Name: STD GLENOSPHERE TRIAL D38MM
• Common Device Name: EXTREMITY INSTRUMENTS : GLENOSPHERE TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20764509
• Report Number: 1818910-2024-24394
• Device Sequence Number: 9292095
• Product Code: HWT
• UDI-Device Identifier: 10603295115984
• UDI-Public: (01)10603295115984(10)5556137
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Followup,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: 230760138
• Device Lot Number: 5556137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 11/21/2024; 11/28/2024; 02/11/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 11/26/2024; 12/03/2024; 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2023
• 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