MAUDE Adverse Event Report: AESCULAP AG ENNOVATE COUNTER TORQUE L-HANDLE; PREVIOUSLY REPORTED

Model Number	SZ282R
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
According to the complaint description the surgeon used a hammer to seat the counter torque and there was no impact to patient.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00759 (b)(4).9610612-2020-00760 (b)(4).
Event or Problem Description
Associated medwatch-reports: 2916714-2020-00618, 2916714-2020-00648.
Additional Manufacturer Narrative
Reference code sz282r.Device name ennovate counter torque l-handle.Serial number n/a.Batch number unknown.Udi device identifier (b)(4).Udi production identifier unknown.Basic udi-di n/a.Unit of use udi-di (b)(4).Manufacturing date unknown.No product at hand.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Explanation and rationale, conclusion: in similar cases as the described, the rod persuader was not completely / correct attached at the pedicle screw.This leads to the jamming of the instrument.The ifu figures out, to ensure the correct attaching to the head of the pedicle screw.Therefore we assume a handling error as the most likely root cause.Corrective action: a capa is not necessary.

• Brand Name: ENNOVATE COUNTER TORQUE L-HANDLE
• Common Device Name: PREVIOUSLY REPORTED
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10765433
• Report Number: 2916714-2020-00648
• Device Sequence Number: 3195948
• Product Code: LXH
• UDI-Device Identifier: 04046964700309
• UDI-Public: 4046964700309
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020
• Report Date (Section F): 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SZ282R
• Device Catalogue Number: SZ282R
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/10/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 12/05/2020
• 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: Required Intervention
• Date Report Sent to FDA: 12/04/2020