MAUDE Adverse Event Report: SYNTHES RIA DRIVE SHAFT; REAMER

Catalog Number 351.718S

Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problem No Code Available (3191)

Event Date 05/31/2018

Event Type  Injury  

Event Description

During reaming using a synthes ria drive shaft, the drive shaft broke inside the patient's right femur.Surgeon was using the instrument at the time of the occurrence.Fragments were left inside the femur.Surgeon washed out the femur with copious amounts of irrigation but 2 pieces of metal drive shaft remained inside the femur.The rep for synthes was in the room and was notified and the remaining parts of the drive shaft were taken off the field and taken by the rep to be analyzed by synthes.Ria drive shaft- (b)(6) 2018.

• Brand Name: RIA DRIVE SHAFT
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES; west chester PA 19380
• MDR Report Key: 7645694
• MDR Text Key: 112843763
• Report Number: MW5078128
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 351.718S
• Device Lot Number: H576202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Is the Reporter a Health Professional?: Yes
• 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): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 101