MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. COR/TARI ANT STEM INSERT SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number D259807440

Device Problems Component Missing (2306); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2016

Event Type  malfunction  

Event Description

During left total hip replacement surgery it was noted that a small piece of an instrument (approx.2 x 3 x 4 mm) was missing.The wound was searched by surgeons.Images were taken with the c-arm and reviewed as negative for foreign body by radiology.Ehr review finds detailed documentation of event and no patient harm.There were some concerns about one of the instruments being broken.Intraoperative x-rays showed no residual piece to the instrument in the wound or deep tissues.

• Brand Name: COR/TARI ANT STEM INSERT SHAFT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic dr.; warsaw IN 46582
• MDR Report Key: 6233212
• MDR Text Key: 64175760
• Report Number: 6233212
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: D259807440
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR