MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE BODY SZ 12 -5 TR; EXTREMITY INSTRUMENTS : PROXIMAL BODY TRIALS

Model Number	2100-40-000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the o ring has broken.No adverse event involving patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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 medwatch, a follow-up medwatch 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 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.H10 additional narrative: added: b5, h6 (impact code) 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
Additional information was received and stated as follows: 1.Did it break into two or more pieces? if no, please specify what is the alleged deficiency of the instrument.Is it bent, cracked, stripped, worn, or cross-threaded? : the o ring is split as per the pictures i sent of it on the initial report.2.Were all pieces of the broken instrument retrieved from the patient? : i was told it happened in sterile services not in the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary <> the device associated with this report was returned to depuy synthes for evaluation.<> the overall complaint was confirmed as the observed condition of the [global unite body sz 12 -5 tr] would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 records evaluation (mre) was not performed.
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.H10 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.The photo investigation found the colored ring broken, confirming the reported allegation additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: GLOBAL UNITE BODY SZ 12 -5 TR
• Common Device Name: EXTREMITY INSTRUMENTS : PROXIMAL BODY TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17073491
• Report Number: 1818910-2023-11704
• Device Sequence Number: 5886015
• Product Code: HWT
• UDI-Device Identifier: 10603295085577
• UDI-Public: 10603295085577
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 06/06/2023

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 Model Number: 2100-40-000
• Device Catalogue Number: 210040000
• Device Lot Number: 7934164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 06/12/2023; 07/14/2023; 08/28/2023; 08/29/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 06/15/2023; 07/17/2023; 08/29/2023; 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2014
• 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