MAUDE Adverse Event Report: AESCULAP AG ENNOVATE MIS DOWNTUBE SHORT; ENNOVATE INSTRUMENTS

Model Number	SZ378R
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported to aesculap inc.That a ennovate mis downtube short (part # sz378r) was used during a minimally invasive spine (mis) fixation procedure performed on (b)(6) 2021.According to the complainant, the physician assistant over rotated the down-tube removal key, which left the tip still slightly in the screw.Reportedly, the tip detached, after rocking and twisting the tube.The loose tip was retrieved from the proximal area of the wound.The wound was irrigated, and then visually inspected.Additionally, the user stated that the first generation downtube removal key was used.The account has since been trained and switched over to the newer version.The complaint device was returned to the manufacturer for evaluation.Additional information was received which revealed that the procedure was delayed approximately 5-7 minutes.The patient was under anesthesia.The final outcome was not affected by the event.The adverse event / malfunction was filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: ENNOVATE MIS DOWNTUBE SHORT
• Common Device Name: ENNOVATE INSTRUMENTS
• 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: 11474643
• Report Number: 9610612-2021-00222
• Device Sequence Number: 4523608
• Product Code: LXH
• UDI-Device Identifier: 04046964719561
• UDI-Public: 4046964719561
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2022

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
• Operator of Device: Health Professional
• Device Model Number: SZ378R
• Device Catalogue Number: SZ378R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown