MAUDE Adverse Event Report: AESCULAP AG ENNOVATE TRANSCONNECTOR 50-60MM STERILE; SPINE SURGERY

Model Number SX950TS

Device Problem Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with sx950ts-ennovate trans-connector 50-60mm sterile.According to the complaint description, it was reported that the product had a deviation.Currently no more information available.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference: (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: at first we made a visual inspection of the connector.Here we noticed, that one of the clamping rocker was complete out of position (loose).The cause for it was a bent up interface between the tightening screw and the rocker.The rocker arms of the damaged rocker are complete bent up, a catch of the clamping screw is not more possible.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2(5) probability of occurrence) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results there is capa is not necessary.

Event Description

Intra operative no function.

• Brand Name: ENNOVATE TRANSCONNECTOR 50-60MM STERILE
• Type of Device: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10984317
• MDR Text Key: 220768493
• Report Number: 9610612-2020-00870
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K180433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SX950TS
• Device Catalogue Number: SX950TS
• Device Lot Number: 52507955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1