MAUDE Adverse Event Report: DEPUY SYNTHES INC. DEPUY REAMER SHAFT; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Device Problem Break (1069)

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

Event Date 08/27/2010

Event Type  malfunction  

Event Description

Prior to placement, the reamer shaft came apart on the operative field.All parts were not accounted for,therefore, and intraoperative x-ray was performed which resulted negative.

• Brand Name: DEPUY REAMER SHAFT
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES INC.; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 16784092
• MDR Text Key: 313718281
• Report Number: 16784092
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/19/2023,08/30/2010

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female