MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CALCAR MILL MEDIUM; HIP INSTRUMENTS : CUTTING INSTRUMENTS

Model Number 2001-48-000

Device Problems Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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 the calcar planers became dull during case.All pieces retrieved and surgery was not delayed.Other calcar planer was available as back up.

Manufacturer Narrative

Product complaint # (b)(4).Mfr# 1818910-2022-06014 is being retracted since it was found to be a duplicate of mfr# 1818910-2022-05681.Mfr# 1818910-2022-05681 will be kept for investigation purposes.

• Brand Name: CALCAR MILL MEDIUM
• Type of Device: HIP INSTRUMENTS : CUTTING INSTRUMENTS
• 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: 13993923
• MDR Text Key: 288473596
• Report Number: 1818910-2022-06014
• Device Sequence Number: 1
• Product Code: LYS
• UDI-Device Identifier: 10603295080015
• UDI-Public: 10603295080015
• 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
• Report Date: 04/04/2022

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
• Device Operator: Health Professional
• Device Model Number: 2001-48-000
• Device Catalogue Number: 200148000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 04/27/2022
• Supplement Dates FDA Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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