MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYSPINE STANDARD DRILL GUIDE T07; SURGICAL INSTRUMENT FOR SPINE SURGERY

Catalog Number 7.0107

Device Problem Fitting Problem (2183)

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

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 06 may 2019: lot 01443s: (b)(4) items manufactured and released on 03-apr-2019.Expiration date: 2019-09-06.No anomalies found related to the problem.Clinical evaluation performed by medical affairs director: according to the report, the surgery has been delayed due to additional preparation required in order to position the guides.This was caused by deformity and thoracic dimensions that could not be taken into consideration at the time of guide planning.The surgery was completed with the use of the guides.The guides were manufactured as custom made devices according to the specifications of the prescription issued by the surgeon; no unconformity to the prescription could be identified.Hence, the surgical delay, deemed not critical by the surgeon, was not caused by a defect of the device.Mysolution department analysis: it is confirmed that there was a costal interference between the myspine standard guides from t07 to t10 and the patient's ribs.As per procedure in force the interference control is not performed between standard myspine guides and ribs.Additional instrument involved (k132788): 7.0108 myspine drill guide t08, lot: 01443s; 7.0109 myspine drill guide t089, lot: 01443s; 7.0110 myspine drill guide t10, lot: 01443s.

Event Description

Standard myspine guides from t7 to t10 didn't fit well with the corresponding vertebrae in situ due to costal interference.The surgeon had to prepare also the thoracic costotransverse joint in order to apply the guide.Some material was removed from the ribs to allow the use of the guides.The surgery was completed successfully with a delay of 20 minutes considered as not critical by the medical staff.

• Brand Name: MYSPINE STANDARD DRILL GUIDE T07
• Type of Device: SURGICAL INSTRUMENT FOR SPINE 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: 8599632
• MDR Text Key: 144976025
• Report Number: 3005180920-2019-00356
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 07630030856556
• UDI-Public: 07630030856556
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K132788
• 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: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2019
• Device Catalogue Number: 7.0107
• Device Lot Number: 01443S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 13 YR
• Patient Weight: 55