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

Model Number	SZ378R
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap inc.That an ennovate mis downtube short (part # sz378r) was used during a minimally invasive transforaminal lumbar interbody fusion (tlif) procedure performed on (b)(6) 2021.According to the complainant, during the surgical procedure, the attachment mechanism of the device dislodged and stuck to the pedicle screw.An x-ray was performed to confirm the part location, and then the surgeon retrieved the fragment from the patient.A surgical delay of approximately 10 minutes was reported.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of the intervention performed.Although requested, additional information has not been made available.The adverse event is filed under aag reference xc (b)(4); cc (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were not able to be reviewed as no lot number was made available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Event or Problem Description
No changes required.

• Brand Name: ENNOVATE MIS DOWNTUBE SHORT
• Common Device Name: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11682152
• Report Number: 2916714-2021-00052
• Device Sequence Number: 14216057
• 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: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2022
• Report Date (Section F): 04/14/2021

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 04/07/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/14/2021