MAUDE Adverse Event Report: ZIMMER LAG SCREW REAMER

Model Number 00-2490-032-44

Device Problems Break (1069); Detachment Of Device Component (1104); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/27/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, the pt underwent left hip replacement surgery.During the use of the lag screw reamer, the tip of the reamer and fragments broke off and imbedded in the pt's bone.

• Brand Name: LAG SCREW REAMER
• Type of Device: LAG SCREW REAMER
• Manufacturer (Section D): ZIMMER; 1800 west center st.; warsaw IN 46581 070
• MDR Report Key: 4847383
• MDR Text Key: 18004751
• Report Number: MW5043066
• Device Sequence Number: 1
• Product Code: HTO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/02/2015

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: 00-2490-032-44
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR