MAUDE Adverse Event Report: JOHNSON & JOHNSON DEPUY - ORTHOPAEDICS. INC; SYNTHES - SWISS

Model Number SWISS 320.062

Device Problems Break (1069); Device, or device fragments remain in patient (1527)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/13/2021

Event Type  malfunction  

Event Description

During a closed elbow procedure the drill bit broke off and lodged into the bone.X-ray revealed location of drill bit in bone and determined to be "non­ retrievable.".

• Brand Name: JOHNSON & JOHNSON DEPUY - ORTHOPAEDICS. INC
• Type of Device: SYNTHES - SWISS
• MDR Report Key: 11731420
• MDR Text Key: 247891948
• Report Number: 11731420
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SWISS 320.062
• Device Catalogue Number: 0123
• Device Lot Number: 85P2044
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2021
• Distributor Facility Aware Date: 04/14/2021
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR