MAUDE Adverse Event Report: AESCULAP AG ENNOVATE SET SCREW STERILE; IMPLANTS POSTERIOR STABILISATION

Model Number SY001TS

Device Problem Difficult to Open or Remove Packaging Material (2922)

Patient Problem Insufficient Information (4580)

Event Date 10/06/2020

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 a sy001ts - ennovate set screw sterile.According to the complaint description the set screw fell on the floor during surgery.Type of surgery: th11-l1 burst.A nurse dropped the set screw on the floor when take it off from the blister pack.The inner box was tightly fixed, the nurse tried to take it off and dropped it.There was no patient harm reported.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Visual investigation: unfortunately we only received the cardboard- box, the sealing- label and the implant.An analysis of these parts does not make sense with regard to the claimed defect.We did not received the inner and the outer blister, most likely the root causes for the described problem.Batch history review: 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(s) with this error pattern.The current failure rate is within the risk analysis and therefore acceptable.Conclusion and measures / preventive measures: on the basis of the current information and the investigation results, a clear conclusion can not be drawn.Because the component causing the problem (blister / blisters) was / were not included, a failure analysis and a definitive root cause determination is not possible.

• Brand Name: ENNOVATE SET SCREW STERILE
• Type of Device: IMPLANTS POSTERIOR STABILISATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10764713
• MDR Text Key: 238838547
• Report Number: 9610612-2020-00810
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K180433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SY001TS
• Device Catalogue Number: SY001TS
• Device Lot Number: 52614762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1