MAUDE Adverse Event Report: AESCULAP AG ENNOVATE SET SCREW STERILE; INSTRUMENTS POSTERIOR STABILISION

Model Number SZ228R

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 03/18/2021

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 sz228r - ennovate torque wrench handle 10nm.According to the complaint description, the screw loosened 6 weeks after surgery.L1-l3, ennovate mis and t-space peek.Initial surgery date: (b)(6) 2021.Revision surgery: (b)(6) 2021.A revision surgery was necessary.Additional information was not provided.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00304 ((b)(4)- sy001ts), 9610612-2021-00305 ((b)(4)- sy001ts), this report ((b)(4)- sz228r).

Manufacturer Narrative

Associated medwatch-reports: 9610612-2021-00304 (400507867 - sy001ts); 9610612-2021-00305 (400507868 - sy001ts).Investigation results: leading device: reference code: (b)(4).Device name ennovate set screw sterile.Serial number n/a.Batch number 52627439.Manufacturing date 06.08.2020.Reference code: (b)(4).Device name ennovate set screw sterile.Serial number n/a.Batch number 52513083.Manufacturing date 28.03.2019.Reference code device name corresponding internal (involved component) sz228r ennovate torque wrench handle 10nm.The set screws arrived in decontaminated condition.Failure description except for the normal wear of explanted screws, the implant exhibit no outwardly defects.Used test- and analysis- equipment: digital-camera "panasonic dmc tz8"; microscope "keyence- vhx 5000 " eq.-nr.2000024840.We made a visual inspection of the received two set- screws.At first we investigated the hexagon of screw "a".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 bottom of the screw.Here we found star shaped signs of abrasion, caused by a slipped rod.In the next step we investigated the hexagon of screw "b".Here we found no signs of wear or damages.The bottom of screw "b" exhibit semicircular wear pattern which is a hint for a not correct tightened screw over a not correct (tilted) placed rod.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.There are no similar complaints against the same lot number(s) 52627439 with this error pattern.There is one similar complaints against the same lot number(s) 52513083.Explanation and rationale: 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.A material failure or a manufacturing error can be excluded.Conclusion and root cause: due to the current deviation and according to the explanation and rationale, the root cause of the problem is most probably usage-related.A capa is not necessary.

• Brand Name: ENNOVATE SET SCREW STERILE
• Type of Device: INSTRUMENTS POSTERIOR STABILISION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11649219
• MDR Text Key: 261739524
• Report Number: 9610612-2021-00306
• Device Sequence Number: 1
• Product Code: HXC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SZ228R
• Device Catalogue Number: SZ228R
• Device Lot Number: 52585585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR