MAUDE Adverse Event Report: MONUMENT DRIVE SHAFT MINIMUM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Device Problem Break (1069)

Patient Problems Fall (1848); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/12/2017

Event Type  Death  

Event Description

It was reported on (b)(6) 2017 that during a revision reamer/irrigator/aspirator (ria) bone graft harvesting on (b)(6) 2017, the drive shaft-minimum 520mm length-for use with ria broke at the tip.The original surgery for a hip repair was performed with stryker devices.The patient fell post-op and required the stryker device to be revised to a total hip replacement.During the revision of the stryker device the ria drive shaft broke.Upon completion of the surgery, the patient coded on the table and had to be stitched up right away.The patient was rushed to the emergency room (er) where the patient was pronounced dead approximately 15 minutes later.There were no fragments left in the patient and despite the broken shaft, the surgery was completed successfully.There was no surgical delay, no additional x-rays or medical interventions needed.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DRIVE SHAFT MINIMUM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MONUMENT
• MDR Report Key: 17533839
• MDR Text Key: 321042989
• Report Number: MW5140742
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1