MAUDE Adverse Event Report: AESCULAP AG ENNOVATE SET SCREW STERILE; SPINE SURGERY

Model Number SY001TS

Device Problem Material Frayed (1262)

Patient Problem Failure of Implant (1924)

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 sy001ts-ennovate set screw sterile.According to the complaint description, it was reported that a revision surgery due the position of the screw was necessary.An ennovate lumbar construct had been found in post ct scans to have failed where the rod had popped out from the screw head at one end of the construct and the set screw sitting sideways on top of the same screw tulip, however the screw remained in place.The revision case involved removing this screw and set screw and replacing it with a new screw of the same size and x3 new set screws, one in the new screw and x2 closest to the revised screw.He reused the rods and did not remove anything else.Originally this was a lumbar fixation using a total of 6 screws.A revision surgery was necessary.It was planned for ca.(b)(6) 2021.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under (b)(4) reference (b)(4).Associated medwatch-reports: 9610612-2021-00623 ((b)(4) sy624ts).9610612-2021-00622 ((b)(4) sy001ts).

Manufacturer Narrative

Updated b5: involved component.Updated d9: date of device returned to manufacturer.Updated h6: codes.Investigation results: visual investigation: we received one set screw and one pedicle screw for investigation.At the first sight, the screws showing no damages or defect.We made a visual inspection of the set- screw.At first we investigated the hexagon of the screw.The hexagon of this screw exhibit no signs of wear or damages which were signs for a not correct applied hex- key.In the next step we investigated the thread of the screw.Here we found signs of wear an abrasion but not yet to a critical extent.After that we inspected the bottom of the screw.Here we found circular wear caused by tightening the screw over a not correct (tilted) applied rod.A look into the head of the enclosed pedicle screw confirms the assumption that the connecting rod did not rest horizontally in the screw heads.We found wear only at one flank of the sy624ts, the other flank shows no signs of wear.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 4 (5) x probability of occurrence 2(5)) 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 a capa is not necessary.

Event Description

Correction: added involved component.Involved component: sy624ts - ennovate polyax.Screw 5.5x45mm canulated - lot: 52682101.Associated medwatch-reports: 9610612-2021-00623 (400526943 sy624ts).9610612-2021-00622 (400526944 sy001ts).

• Brand Name: ENNOVATE SET SCREW STERILE
• Type of Device: SPINE SURGERY
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12507138
• MDR Text Key: 272509469
• Report Number: 9610612-2021-00622
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K180433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SY001TS
• Device Catalogue Number: SY001TS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: SY624TS - LOT 52682101.
• Patient Outcome(s): Required Intervention