MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS ARCADIUS XP L IMPLANT 4° 25X35X10MM; INTERBODY FUSION

Model Number SO810P

Device Problem Break (1069)

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

Event Date 02/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that during inserting an implant it broke and had to be replaced by another one.There was a thirty minute delay in surgery.

Manufacturer Narrative

Investigation: the broken implant has been examined visually and microscopically with a keyence vhx 5000 digital microscope.A microscopic investigation was performed of the fracture surface.It was found that on the crack origin which is located at the beginning of the thread, traces of a sharp instrument like a punch could be seen.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers.The device history file has been checked and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from this batch.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 user related.Rational: we assume that a high forced using of the punch at an incorrect angle caused the crack of the implant.Furthermore the device exhibits no indications of a manufacturing or material problem.Capa (b)(4) was created.

• Brand Name: ARCADIUS XP L IMPLANT 4° 25X35X10MM
• Type of Device: INTERBODY FUSION
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6403586
• MDR Text Key: 69912319
• Report Number: 9610612-2017-00085
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K111122
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SO810P
• Device Catalogue Number: SO810P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/14/2017
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other