MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US COR/TRI POST STEM INSERT SHAFT; HIP INSTRUMENTS : INSERTION DEVICES

Model Number	2598-07-470
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, the patient underwent the surgery via bha.In the surgery, the handle in question and the shaft in question remained engaged and could not be removed, making replacement impossible.After hammering several times, when the surgeon tried to replace the shaft, it did not come off.The instruments were inspected before preoperative sterilization, and they were easy to attach and detach at that time.The surgery was completed successfully within 30 minutes delay.No further information is available.
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 information is obtained that was not available for the initial, a follow-up 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.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: the device associated with this report was returned for analysis.Visual examination of the device did not confirmed, the allegation.The mating devices were able to be disassembled/assembled as intended.A functional test was performed with the involved mating device (259807460).And devices were able to be disassembled/assembled as intended.Depuy synthes considers, the investigation closed at this time.Should additional information be received, the information will be reviewed.And the investigation may be re-opened as necessary.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: COR/TRI POST STEM INSERT SHAFT
• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16094056
• Report Number: 1818910-2023-00286
• Device Sequence Number: 6703765
• Product Code: HWR
• UDI-Device Identifier: 10603295148456
• UDI-Public: 10603295148456
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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 Model Number: 2598-07-470
• Device Catalogue Number: 259807470
• Device Lot Number: MT106916
• 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: 12/16/2022
• Supplement Date Received by Manufacturer: 01/24/2023; 03/10/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 01/25/2023; 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• 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