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

Model Number	SZ378R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: visual investigation: at the tip of both instruments one of the two catches is missing.The broken off parts were not enclosed.We made a visual inspection of the instrument.Here we found that one of the two arms was found bent and stuck / jammed in the guiding slot.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 number.Explanation and rationale: without further knowledge about the circumstances we expect, that the surgeon spread the downtube not completely with the removal key as mentioned in the instructions for use (ifu), so that the catch bent during removal.Hints in the ifu for removing the downtube from the pedicle screw - loosen gold colored sleeve a on downtube 1-2 clockwise revolutions until the line marking is no longer visible note - if necessary, the locking wrench for downtube can be used to make loosening easier insert removal key from the top into the downtube up to the stop so that the line marking terminates flush with the head of the downtube twist removal key by 90 degrees to the downtube and remove from the site together with the downtube by pulling on the removal key repeat procedure for additional downtubes conclusion and measures / preventive measures: based upon the investigation results, the root cause is most probably usage-related.Based upon the investigations results a capa is not necessary.
Event or Problem Description
It was reported that there was an issue with sz378r - ennovate mis downtube short.According to the complaint description, the retaining tabs are broken.The broken pieces were retrieved & discarded.An additional medical intervention was necessary.Additional information was not provided.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00360 (400510390 - sz378r).

• 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: 12555439
• Report Number: 9610612-2021-00658
• Device Sequence Number: 4306622
• Product Code: LXH
• UDI-Device Identifier: 04046964719561
• UDI-Public: 4046964719561
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2021

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
• Device Lot Number: 52416341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/30/2021
• 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