MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRIAL SHELL TRAY 47/48-65/66; HIP INSTRUMENTS : INSTRUMENT CASES

Model Number 2217-60-013

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a loaner set of instruments was received back from a hospital that contained residual debris and had to be returned to the site for additional cleaning by their sterile processing department.

Manufacturer Narrative

Product complaint # (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: TRIAL SHELL TRAY 47/48-65/66
• Type of Device: HIP INSTRUMENTS : INSTRUMENT CASES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10417415
• MDR Text Key: 203310279
• Report Number: 1818910-2020-18272
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 10603295099222
• UDI-Public: 10603295099222
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2217-60-013
• Device Catalogue Number: 221760013
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1