MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM MILLER SHELL SZ 29; HIP INSTRUMENTS : INSERTION DEVICES

Model Number 2576-05-029

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Not Applicable (3189)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Visual inspection found a small crack in the black marker band and a set screw fell out.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.

Event Description

Srom pinnacle hip replacement; the screw in the miller shell fell out during use.No ae to patient.

• Brand Name: SROM MILLER SHELL SZ 29
• Type of Device: HIP INSTRUMENTS : INSERTION DEVICES
• 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: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10203126
• MDR Text Key: 196771057
• Report Number: 1818910-2020-14557
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295145585
• UDI-Public: 10603295145585
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2576-05-029
• Device Catalogue Number: 257605029
• Device Lot Number: SO2010237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2013
• 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