MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM TRI BAND CONE REAMER 25; HIP INSTRUMENTS : REAMERS

Model Number 2576-02-025

Device Problem Illegible Information (4050)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2020

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.Investigation summary: examination of the returned instrument confirmed the complaint.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

It was reported that srom instruments are difficult or impossible to read the sizing.Surgeon is concerned this is a patient safety issue and instruments should be replaced.No surgical delay.

• Brand Name: SROM TRI BAND CONE REAMER 25
• Type of Device: HIP INSTRUMENTS : REAMERS
• 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: 9875132
• MDR Text Key: 184777259
• Report Number: 1818910-2020-09148
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295145370
• UDI-Public: 10603295145370
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2576-02-025
• Device Catalogue Number: 257602025
• Device Lot Number: AB1005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2003
• 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
• Patient Age: 60 YR