MAUDE Adverse Event Report: AESCULAP AG ENNOVATE POLYAX.SCREW 6.5X50MM SOLID; SPINE SURGERY

Model Number SY135TS

Device Problem Device Damaged by Another Device (2915)

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

Event Date 08/25/2021

Event Type  malfunction  

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 sy135ts - ennovate polyax.Screw 6.5x50mm solid.During the surgery, the screw was found to be not fully seated on driver and scrub technician could not back the screw off.A second screw was opened and the backup driver was utilized to avoid delaying the procedure.The affected screw and driver were removed from the sterile field and the aesculap representative was able to separate the two.The driver seemed fine, but the screw was observed to possibly be cross-threaded.There was no described patient harm.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Additional information - b5.According to our final reporting evaluation, this event is considered no longer reportable for the following reason: no product defect noted in 8d investigation report.Investigation: visual inspection: the thread inside the head which makes up the set screw is in a faultless condition and shows only slight wear, most likely from the trial during the surgery.The outer flanks fo the head are also in a good condition with slight wear marks.The hexagon inside the head, which picks up the driver, is in a faultless condition and shows no signs of wear or deformation.In the next step, we made an attempt to connect a screwdriver on the screw.The connection between the screwdriver and the screw was possible without any problems.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specifications valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Conclusion and measures / preventive measures: based upon the investigation results, a defect cannot be found; the complained problem could not be confirmed.There is no indication for a material-, manufacturing- or design-related failure.Based on the investigation results a capa is not required.

Event Description

Update: the procedure was a posterior lumbar interbody fusion (plif).

• Brand Name: ENNOVATE POLYAX.SCREW 6.5X50MM SOLID
• 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: 12489104
• MDR Text Key: 271936036
• Report Number: 9610612-2021-00612
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04046964989209
• UDI-Public: 4046964989209
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SY135TS
• Device Catalogue Number: SY135TS
• Device Lot Number: 52679891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1