MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ACETABULAR REAMER

Device Problem Material Separation (1562)

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

Event Date 11/11/2022

Event Type  malfunction  

Event Description

During an anterior hip replacement and when reaming the acetabular side, the 52mm reamer separated.The depuy tray pinnacle graters (set with all the reamers) was being used and the 52mm reamer.Each reamer is made up of two pieces.There is the bottom portion that attaches to the power and an upper part where the grater resides.When the surgeon removed the power that the grater was attached to, initially only the bottom part came out.A bone hook was used to remove the top portion of the reamer.Verified with c-arm to make sure nothing was retained.Surgery continued from that point without incident.Fda safety report id (b)(4).

• Brand Name: ACETABULAR REAMER
• Type of Device: REAMER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 15855885
• MDR Text Key: 304332727
• Report Number: MW5113448
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEPUY TRAY PINNACLE GRATERS
• Patient Age: 58 YR
• Patient Sex: Male