MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE CONNECTOR FOR DISTAL SPACER; SURGICAL INSTRUMENT FOR KNEE SURGERY

Catalog Number 02.18.10.0031

Device Problem Device Fell (4014)

Patient Problem No Code Available (3191)

Event Date 10/08/2019

Event Type  Injury  

Event Description

During the primary knee surgery, and while the surgeon grabbed the connector rod to make a femoral cut, the connector rod dropped out of his hands and fell.The surgeon asked for another connector rod which was not available.The connector rod had to be flashed for 24 minutes to be used in the surgery.There was a 24- minute delay in the case.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE CONNECTOR FOR DISTAL SPACER
• Type of Device: SURGICAL INSTRUMENT FOR KNEE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 9284064
• MDR Text Key: 165575283
• Report Number: 3005180920-2019-00938
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07630040782524
• UDI-Public: 07630040782524
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.18.10.0031
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR