MAUDE Adverse Event Report: AESCULAP AG ENNOVATE POLYAX.SCREW 7.5X55MM CANULATED; IMPLANTS POSTERIOR STABILISATION,

Model Number SY646TS

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)

Event Date 06/17/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation - the implant arrived in a decontaminated condition.The head of the sy646ts arrived without the thread body.The head exhibits no damage or wear.Use of a digital camera (panasonic dmc tz8) confirmed the screw exhibits no defects or wear.Batch history review - the manufacturing documents have been checked and found to be according to specifications during the time of production.There are no further complaints with this lot at hand.Conclusion and root cause - the root cause for the problem is most probably usage related.Rationale - the possible dismantling of the screw (head/body) is not a malfunction.The ifu points out the possibility of a dismantling during revision and the necessary actions to remove the thread body.Corrective action: according to sa de13-m-4-2-04-000-0 there is no capa necessary.Should further information regarding this case become available, a supplemental report will be submitted.

Event Description

It was reported that there was an intraoperative issue with an ennovate screw that resulted in a surgical delay.The reported case involved a revision fortex system with lumbar 2 - lumbar 5 implantation of ennovate at thoracic 10 - lumbar 5, this ennovate screw was implanted using the applicable screwdriver.On x-ray , the screw should then be turned further into the pedicle, breaking off the torx.Screw was then unscrewed with the 2nd sz381r to cut thread.While removing it there was a loud crack and the screw broke into 2 parts.One part remained in the patient and could not be unscrewed as it "sat too low".Surgery was delayed 15 minutes.Details about the surgical outcome and patient data were not provided.Additional information has been requested.Associated medwatch: 9610612-2019-00459 ( sz381r- screwdriver).

• Brand Name: ENNOVATE POLYAX.SCREW 7.5X55MM CANULATED
• Type of Device: IMPLANTS POSTERIOR STABILISATION,
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: kerstin rothweiler ; am aesculap-platz; tuttlingen, badden-wurttemberg 78532 ; GM 78532
• MDR Report Key: 8806490
• MDR Text Key: 151579634
• Report Number: 9610612-2019-00458
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K180433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2019

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
• Device Operator: Health Professional
• Device Model Number: SY646TS
• Device Catalogue Number: SY646TS
• Device Lot Number: 52383854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2017
• 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