MAUDE Adverse Event Report: LEKSELL RONGEUR; ORTHOPEDIC SURGICAL INSTRUMENT

Model Number NL632

Device Problem Component Missing (2306)

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

Event Date 02/13/2018

Event Type  malfunction  

Event Description

Pt s/p total knee arthroplasty.Operating room leadership was notified by central sterile processing that there was a piece missing from the tip of a rongeur equipment that may have been utilized during the case when they were processing instruments from the case.The damaged instrument was not noted by the team in the room.There were 2 rongeurs on the case and only one was used.Surgeon immediately notified and he stated that he did not note any issues while using the instruments during the case.A knee xray was performed which showed no radiopaque foreign body status post left total knee arthroplasty.

• Brand Name: LEKSELL RONGEUR
• Type of Device: ORTHOPEDIC SURGICAL INSTRUMENT
• MDR Report Key: 7276198
• MDR Text Key: 100463088
• Report Number: MW5075321
• Device Sequence Number: 1
• Product Code: HTX
• 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: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL632
• Was Device Available for Evaluation?: Yes
• 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): Other
• Patient Age: 63 YR
• Patient Weight: 104