MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYSPINE S01 DRILL BASED GUIDE

Catalog Number	7.0726
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other device involved: myspine s01 vertebra reference 7.0706 (k173472); batch review performed on 12 december 2018; lot 00981s: (b)(4) items manufactured and released on 31 october 2018.Expiration date: 2019-03-14; no anomalies found related to the problem.Investigation performed by mysolution department on november 21, 2018.Our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.
Event or Problem Description
The surgeon was not able to drill safety because the sleeve part length of myspine s01 drill based guide was too short in comparison with others.Moreover it was not able to set on the spinal bone stable.The surgeon drilled only the entry point under the imaging and proceeded freehand drilling causing a critical delay in the surgery.
Additional Manufacturer Narrative
Visual inspection performed on the 19 december 2018 by mysolution manager: after the visual inspection of the myspine guide, we confirm the guide has been designed according to the procedure in force.The model is conform.

• Brand Name: MYSPINE S01 DRILL BASED GUIDE
• Common Device Name: DRILL BASED GUIDE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8155012
• Report Number: 3005180920-2018-00986
• Device Sequence Number: 1961399
• Product Code: PQC
• UDI-Device Identifier: 07630040717571
• UDI-Public: 07630040717571
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2019
• Device Catalogue Number: 7.0726
• Device Lot Number: 00981S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other