MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HIP CORE 2 INSTR CASE COMPLETE; HIP INSTRUMENTS : INSTRUMENT CASES

Model Number	2611-20-000
Medical Device Problem Codes	Break (1069); Crack (1135); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
On (b)(6) 2022 the spd department at north chicago va (ucn 400422) denied the delivery of six trays.The hospital staff observed damage on the brackets which hold the instruments in place within the graphic cases as well as the general condition of the plastic tray inserts.This issue was identified on june 3rd and replacement trays were delivered on june 6th for the case that was scheduled on june, 8th.Consultant confirmed that there was no impact or delay in surgical schedule due to this event.
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.
Event or Problem Description
Additional information received.Indicated that, some of the plastic inserts had holes and discoloration, due to what appeared to be some sort of ink transference.As well as, the epoxy coating on the metal pieces that protrude from the tray inserts to hold the instruments in place was cracked/peeling and pulling apart or had completely broken off.
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 inspection found the device had a few metal inserts coting peeling.Additionally, the device was found with cracks and broken pieces at its tray components.The reported condition was confirmed.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 : a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• Brand Name: HIP CORE 2 INSTR CASE COMPLETE
• Common Device Name: HIP INSTRUMENTS : INSTRUMENT CASES
• 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 46581-0988 ; 3035526892
• MDR Report Key: 14855369
• Report Number: 1818910-2022-12015
• Device Sequence Number: 12153240
• Product Code: FSM
• UDI-Device Identifier: 10603295149200
• UDI-Public: 10603295149200
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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,Followup,Followup,Followup
• Report Date (Section B): 06/29/2022

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: 2611-20-000
• Device Catalogue Number: 261120000
• 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: 06/03/2022
• Supplement Date Received by Manufacturer: 07/01/2022; 07/07/2022; 08/01/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 07/05/2022; 07/12/2022; 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CANAL REAMER 14MM BULLET TIP; HIP CORE INSTRUMENT BOT TRAY; HIP CORE INSTRUMENT MID TRAY; HIP CORE INSTRUMENT TOP TRAY; HIP CORE REAMER TRAY
• Patient Sex: Unknown