MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS ORTHOPILOT DISPOS.PASSIVE MARKER STERILE; ORTHOPILOT POSITIONING

Model Number FS617

Device Problems Flaked (1246); Product Quality Problem (1506); Device Issue (2379)

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

Event Date 01/18/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaints: (b)(6).During a tha (total hip arthroplasty) procedure the coating came off the device.Although the coating was detached there was no harm to the patient and no delay in surgery.The surgery was completed by using another device.

Manufacturer Narrative

Investigation: after examining the sphere itself, we noted that the adhesive on the sphere core was not evenly distributed suggesting a problem with the application of the glue.As a result, the reflective film could separate if enough force is applied to the sphere.From the complaint description, the reflective film had come off the sphere in a tha procedure during the cupping portion.Given the vibrational force applied during this portion of a tha procedure, film that was not properly adhered to the sphere core could come off with an impact.Ndi reviewed the risk analysis as part of the review of this complaint.The estimated reported failure rate is between 1/100,00 to 1/,1,000,000 procedures.The reported failure rate is at or less than expected.The lot in question was manufactured in june-2016.Since the time the lot was manufactured, there have been no other complaints of this type.At this point no further corrective actions will be taken.Ndi will continue to monitor for this failure mode.Ndi has forwarded the complaint to the contract manufacturer.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 a manufacturing error.

• Brand Name: ORTHOPILOT DISPOS.PASSIVE MARKER STERILE
• Type of Device: ORTHOPILOT POSITIONING
• 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: 6351565
• MDR Text Key: 68090069
• Report Number: 9610612-2017-00062
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013569
• 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: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: FS617
• Device Catalogue Number: FS617
• Device Lot Number: 4507946732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/07/2017
• Device Age: 4 MO
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2016
• 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