MAUDE Adverse Event Report: AESCULAP AG TSPACE PEEK/XP TRIAL 5° 26X11.5X7MM; SPINE SURGERY

Model Number SN322R

Device Problem Compatibility Problem (2960)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/14/2020

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 tspace peek/xp trial.According to the customer report: the case was reported as "unable to rotate the trial t space sn323r using the insertion instrument sn305r".The surgeon loosened the knob at the end of the handle to rotate the tspace trial, however , the surgeon was not able to rotate the trial because the articulation between the inserter and the trial t space was loose and not controlable.The surgeon ended up positioning the implant a little obliquely, because of inadequate rotation and because desired end position was not obtained by the trial procedure.After the operation , it was observed optically (the trial sn323r) , and found that the hole at its articulation was significantly worn.This wear might have contribueted to this event , although it is hypothetical.Not exactly known if there was surgical delay of over 15 minutes.No patient health hazard.Update: the components used in the surgical procedure are sn323r and sn305r.The other trials were sent as well, because they showed wear when checking them after the surgical procedure was done.Additional patient information is not available.The adverse malfunction is filed under (b)(4).Associated medwatch-reports: 9610612-2019-00956 ((b)(4) sn323r).9610612-2019-00957 ((b)(4) sn305r).9610612-2019-00959 ((b)(4) sn324r).

Manufacturer Narrative

Associated medwatch-reports: 9610612-2019-00956 (400460756 sn323r); 9610612-2019-00957 (400460761 sn305r) 9610612-2019-00958 (400460764 sn322r) report for this case ; 9610612-2019-00959 (400460768 sn324r).Consequences for the patient: according to the available information, there were no negative consequences for the patient.Investigation: at the first step we made a visual and microscopically investigation of the complained trial implant "26x8".Here we found strange dents at one side of the trial implant, likely caused by the attempt to navigate the implant with a additional instrument during the last surgery (complaint issue).In the next step we investigated the different joint planes.At the inner rim of both sides of the hole we found strong dents, wear and burr, also at the interface to the instrument (front end.The additional sent in trial implants (size 7 and 9) exhibit exactly the same wear marks and dents.After that, we investigated the enclosed insertion instrument.At the pick- up and clamping tip we noticed slight wear and deformation.Batch history review: the product does not require a batch management, a batch history review is not possible.Conclusion and root cause: the root cause for the problem is most probably usage related.Rationale the complained trial implant and the other enclosed components exhibit strong wear and deformations on the joint surfaces.A tight and reliable clamping / fixation of the components which each other with such damages is not guaranteed.A material defect or a manufacturing error can be excluded.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action & preventive action) a capa is not necessary.

• Brand Name: TSPACE PEEK/XP TRIAL 5° 26X11.5X7MM
• Type of Device: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9677619
• MDR Text Key: 180121856
• Report Number: 9610612-2019-00958
• Device Sequence Number: 1
• Product Code: HWT
• 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: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SN322R
• Device Catalogue Number: SN322R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Date Manufacturer Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1