MAUDE Adverse Event Report: SYNTHES (U.S.A.) LLC; REAMER

Model Number 309.068

Device Problems Break (1069); Material Puncture/Hole (1504)

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

Event Date 09/11/2018

Event Type  malfunction  

Event Description

Per the surgeon, it was more of a risk to take the broken item out so it was left in the patient.The screw they were in the process of removing was removed successfully.The item that broke is a one time use item placed in the synthes broken screw removal set and processed in spd.The shukla medical screw removal set was the one they originally wanted but had a hole in the blue wrap.

• Brand Name: NA
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES (U.S.A.) LLC; 1303 goshen pkwy; west chester PA 19380
• MDR Report Key: 7893040
• MDR Text Key: 120863441
• Report Number: 7893040
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 309.068
• Device Catalogue Number: 309068
• 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: 09/13/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2018
• 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: 20805 DA