MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HIP CORE 1 INSTR CASE COMPLETE; HIP INSTRUMENTS : INSTRUMENT CASES

Model Number 2611-30-000

Device Problems Break (1069); Crack (1135); Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2022

Event Type  malfunction  

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 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 (b)(6) and replacement trays were delivered on (b)(6) for the case that was scheduled on (b)(6).Consultant confirmed that there was no impact or delay in surgical schedule due to this event.

Event 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.

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.

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.

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.Additional findings were few rubber base components broken and tray component had cracks visible.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.The device's top was not returned.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: HIP CORE 1 INSTR CASE COMPLETE
• Type of Device: 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: 14857125
• MDR Text Key: 303238750
• Report Number: 1818910-2022-12031
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 10603295149255
• UDI-Public: 10603295149255
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2611-30-000
• Device Catalogue Number: 261130000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CANAL REAMER 14MM BULLET TIP; HIP CORE INSTRUMENT BOT TRAY; HIP CORE INSTRUMENT MID TRAY; HIP CORE INSTRUMENT TOP TRAY; HIP CORE REAMER TRAY