MAUDE Adverse Event Report: AESCULAP AG ABC STORAGE TRAY; SPINE SURGERY

Model Number FJ841P

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2019

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 abc storage tray.The lid of the tray detached, when lifting the storage tray, and the sterilized products inside fell onto the non-sterile area.The products inside were re-sterilized while start of the surgical procedure was delayed until the sterilization was done.There was no patient harm.Additional information was not provided.The adverse event/malfunction is filed under (b)(4).

Manufacturer Narrative

General information: the issue occurred intra-operatively and the sample (empty storage tray fj841p) was received for investigation purposes.The hygienic condition was decontaminated.Consequences for the patient: according to the available information, there were no negative consequences for patient.Investigation: the product was received without any packaging.The overall condition is good.Only very little signs of usage could be detected, i.E.Scratches on the metal latches for lid fixation.All components (lid, both insert parts and bottom part) were assembled.The closing latches were all closed.No instruments or other components were inside the tray.A small glued tape was put on the lid, showing the reference number to the complaint in sap ded c3.Furthermore, another glued tape with "abc-14" was found on the top of the lid as well as on two sides of the bottom part.Visual recognizable defects / deviations could not be found.A visual inspection with camera and microscope have been performed.Furthermore, the latches for lid fixation (on all four sides) have been checked on opening and closing behavior.Both investigation steps have not shown any detectable hints for a defect / malfunction on the product.Batch history review: a review of the device quality and manufacturing history records is not possible because the lot number is unknown.No further complaint to this article-batch-combination filed so far.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage.However, without further information, a clear root cause cannot be determined.Rationale: based on the investigation results and the provided information, it was not possible to refer the reported malfunction to a material or manufacturing issue.The latches functioned as intended during the tests, also, the material (latches on the lid as well as counterparts on the tray bottom) did not indicate deformations, cracks or other defects that could have indicated a potential root cause for the reported malfunction.Based on those results, it is likely that the reported malfunction occurred due to an insufficient closing of the latches on the lid, i.E.Caused by a non-complete attaching the lid on the bottom part or similar circumstances.During testing, it was tested how the product behaves with two latches fully closed (over one corner).With lighter movement while holding the tray on the handles at the lid, the bottom part could get detached accordingly.This effect is very likely stronger when tray is loaded with instruments, as usual in clinical usage.However, without further information about the circumstances when the issue occurred, the definitive root cause cannot be determined.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action and preventive action), a capa is not necessary.

• Brand Name: ABC STORAGE TRAY
• Type of Device: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9528468
• MDR Text Key: 179470097
• Report Number: 9610612-2019-00861
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FJ841P
• Device Catalogue Number: FJ841P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1