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

Model Number SY001TS

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Joint Laxity (4526)

Event Date 05/06/2021

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 ennovate set screw sterile - sy001ts.According to the complaint description, after an open ennovate implantation procedure at the end of 2020, a screw loosening with loss of the locking nut occurred.A revision surgery was necessary.Additional information was not available.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00433 ((b)(4)+ sy001ts), 9610612-2021-00435 ((b)(4) + sy001ts), 9610612-2021-00424 ((b)(4)+ sy001ts.Involved components: sy658ts - ennovate polyax.Screw 8.5x70mm canulated - 52383818, sy655ts - ennovate polyax.Screw 8.5x50mm canulated - 52383871, sy706ts - ennovate closed/open domino connect.11mm - 52446745, sy415ts - ennovate straight rod 5.5x150mm - 52473694, ae-qas-sp41 - collect.No.Qas spine posterior stabilis.- batch unknown.

Manufacturer Narrative

Investigation results: visual investigation: at the first sight all set screws exhibit more or less strong signs of wear on the bottom.Investigation was carried out visually and microscopically.At first we investigated the hexagon of screws.The hexagon of this screws exhibit no signs of wear or damages which were signs for a not correct applied hex- key.In the next step we investigated the bottom of the screws.Here we found signs of heavy abrasion, caused by a slipped 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 heavy abrasion at one flank of the sy658ts, the other flank shows no signs of wear.For comparison the head of the other pedicle screw (sy655ts) shows the correct contact pattern of a pedicle screw with the rod correctly positioned.The wear pattern on the bottom of the set screws are a sure hint for tightening the screws over a not correct (tilted) applied rod.The contact pattern in the head of the pedicle screw "x" is a sure hint for tilted applied rods.A material failure or a manufacturing error can be excluded.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 numbers (52406268; 52621311; 52616828 ).There is one similar complaints against the lot number 52461667.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.

• Brand Name: ENNOVATE SET SCREW STERILE
• Type of Device: ENNOVATE IMPLANTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11922846
• MDR Text Key: 265577669
• Report Number: 9610612-2021-00434
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04046964989728
• UDI-Public: 4046964989728
• 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: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• 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
• Device Lot Number: 52621311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Date Manufacturer Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AE-QAS-SP41 - BATCH UNKNOWN; SY415TS - 52473694; SY655TS - 52383871; SY658TS - 52383818; SY706TS - 52446745
• Patient Outcome(s): Required Intervention