MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US EZCLEAN REAM HAND ZIM-HALL FIT; OTHER PRODUCTS

Catalog Number MPF310029

Device Problems Break (1069); Device-Device Incompatibility (2919); Measurement System Incompatibility (2982)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

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

Broken reamer handle.Not engaging in the adapter.Patient status/ outcome / consequences --> no.

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.This does not meet a complaint definition, the electronic complaint record will be voided.

• Brand Name: EZCLEAN REAM HAND ZIM-HALL FIT
• Type of Device: OTHER PRODUCTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8569050
• MDR Text Key: 144248111
• Report Number: 1818910-2019-92128
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MPF310029
• Device Lot Number: 3093689
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1