MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL AMT CASE COMPLETE; HIP INSTRUMENTS : INSTRUMENT CASES

Model Number 2665-99-000

Device Problems Break (1069); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2020

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

Upon inspection, staff noticed severe wear of trays including paint flaking off of metal inserts.Hospital is worried about trays creating debris in the tray wrappers.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.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.

• Brand Name: CORAIL AMT CASE COMPLETE
• Type of Device: HIP INSTRUMENTS : INSTRUMENT CASES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10221189
• MDR Text Key: 197297240
• Report Number: 1818910-2020-14862
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 10603295150015
• UDI-Public: 10603295150015
• 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: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2665-99-000
• Device Catalogue Number: 266599000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1