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 Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results: we made a visual inspection of the fracture surface of the broken off catch nose.Here we found the typically signs of a forced fracture.The device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number with this error pattern.We assume that the surgeon spread the downtube not completely with the removal key as mentioned in the ifu.As a result of this handling the catch broke off during removal.According to the ifu the following points must be observed: " loosen gold colored sleeve on downtube one to two 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° to the downtube and remove from the site together with the downtube by pulling on the removal key repeat procedure for additional downtubes [.]".There for we assume that the root cause is most probably usage related.
Event or Problem Description
It was reported that there was an issue with a ennovate mis downtube.According to the complaint description the retaining lug is broken off intraoperatively but did not remain in situ.There was no patient harm.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).

• 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: 10495986
• Report Number: 9610612-2020-00453
• Device Sequence Number: 2345006
• Product Code: LXH
• UDI-Device Identifier: 04046964719561
• UDI-Public: 4046964719561
• Combination Product (Y/N): N
• Initial Reporter Country: FG
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SZ378R
• Device Catalogue Number: SZ378R
• Device Lot Number: 52509266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1