MAUDE Adverse Event Report: AESCULAP AG ACTIV L INSERTION INSTRUMENT F/H8.5MM; INSTRUMENTS SPINAL MOTION

Model Number FW961R

Device Problem Compatibility Problem (2960)

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

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 the activl insertion instrument.During lumbar disc replacement spinal procedure, the 8.5 inserter was not working properly.It would not securely hold the implant, and the implant would easily come off.A different 8.5 inserter was used instead to complete the case.No intervention was required and there was no patient harm noted.Additional information was not provided.

Manufacturer Narrative

D4 - lot number; h4 - production date.Manufacturing evaluation: the instrument arrived in a decontaminated condition.The instrument arrived in a detached status.At first sight, the instrument exhibits no visible damages.Investigation - a visual and microscopic investigation of the instrument was made.Here we found that one pin of the caudal side was bent and the flanks of the spacer exhibit strong wear.Batch history review - the manufacturing documents have been checked and found to be according to specifications valid at the time of production.There are no further complaints with this lot at hand.Conclusion and root cause - the root cause for the problem is most probably usage related.Rationale - the manufacturing documents are without hints of deviations to the product specifications.A material defect or a manufacturing error can be excluded.Without further knowledge about the circumstances, it appears the damage occurred during sterilization process or a handling error.

• Brand Name: ACTIV L INSERTION INSTRUMENT F/H8.5MM
• Type of Device: INSTRUMENTS SPINAL MOTION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8736720
• MDR Text Key: 149339202
• Report Number: 9610612-2019-00422
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: P120024
• 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: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FW961R
• Device Catalogue Number: FW961R
• Device Lot Number: 52332934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Distributor Facility Aware Date: 05/31/2019
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1