MAUDE Adverse Event Report: AESCULAP AG ENDURO GUIDE F/KEY F/TIBIAL LOCKING RING; KNEE ENDOPROSTHETICS

Model Number NP144PM

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2018

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 intraoperative issue with the enduro instrument.During an orthopedic procedure, the enduro guide did not fit properly on the implant and the holder would not fit over it.It was felt that the guide was not "correct".The surgeon tried to modify the piece during the case but ultimately used a different instrument to complete the implant assembly.There was no patient injury reported but a delay of 15 minutes was noted in order obtain the other instrument.Additional information has been requested.

Manufacturer Narrative

Investigation: no product is at hand.Batch history review: a review of the device quality and manufacturing history records was not possible because the lot number is unknown.Conclusion and root cause: based on the information available it is not possible to determine a possible root cause for the failure.Rationale: in light of the information provided, we can not determine a root cause of the mentioned failure.No capa is necessary.

• Brand Name: ENDURO GUIDE F/KEY F/TIBIAL LOCKING RING
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8249229
• MDR Text Key: 133226219
• Report Number: 9610612-2019-00022
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K101815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NP144PM
• Device Catalogue Number: NP144PM
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/22/2019
• Date Manufacturer Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANT