MAUDE Adverse Event Report: AESCULAP AG ENNOVATE TRANSCONNECTOR 50-60MM STERILE; IMPLANTS POSTERIOR STABILISATION

Model Number SX950TS

Device Problems Product Quality Problem (1506); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2021

Event Type  Injury  

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 transconnector 50-60mm sterile.According to the complaint description, the connection of the device was not possible.Even after several attempts, the surgeon did not manage to fix the cross connector with the rods.The screw always overtightened.There was another implant available.Surgery delay was extended by approx.30 min.An additional medical intervention was necessary.Additional information was not provided nor available.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results visual investigation the product has been analysed visually and microscopically.Slight traces of usage can be found at the cross connector and at the screw heads.On the bottom left side, a misaligned and partially damaged clamp can be detected,shows a correct and undamaged clamp.Due to this misalignment, the reported failure pattern occurred.A tightening of the screw is not possible anymore.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.Acceptable failure occurrence: 100 ppm.Actual failure occurrence: 1767 ppm.The review of the risk assessment revealed that the overall risk level (severity 2(5) probability of occurrence4(5)) according to din en iso 14971 is no longer acceptable.The need to revisit the risk assessment will be requested and further evaluated by the responsible department.Conclusion and measures / preventive measures: based on the provided information and after the investigation, we suspect that the cross connector was not applied correctly to the rod.With an improper position of the connector, a sufficient tightening of the rod is not possible anymore which could also lead to a damaging shown above.After that, a correct tightening is not possible anymore.The error-pattern is a clear hint for a damage caused by too high torque applied to the clamp screw.The corresponding ifu points out to avoid too high torque forces on the screws.There is no indication for a material or manufacturing failure.Based upon the investigations results a capa is not necessary.

• Brand Name: ENNOVATE TRANSCONNECTOR 50-60MM STERILE
• Type of Device: IMPLANTS POSTERIOR STABILISATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11619048
• MDR Text Key: 243930698
• Report Number: 9610612-2021-00270
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04046964995712
• UDI-Public: 4046964995712
• 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: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SX950TS
• Device Catalogue Number: SX950TS
• Device Lot Number: 52581399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention