MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS VEGA PS REMOVABLE TRIAL FEMUR BOX F5; SPECIAL INSTRUMENTS FOR VEGA SYSTEM

Model Number NS825R

Device Problem Break (1069)

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

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaint: usa surgeon lightly impacted and the tab broke off.No patient injury.No delay in surgery.

Manufacturer Narrative

Investigation: no product is at hand.Conclusion and root cause: no product available, and therefore an analysis is not possible.Rational: according to the quality standard, a material defect or production error can be excluded.Without further knowledge about the circumstance and without the product or photos we can not determine the exact cause.There is the possibility of a mechanical overload situation or improper handling as the causal factor.No capa is necessary.

• Brand Name: VEGA PS REMOVABLE TRIAL FEMUR BOX F5
• Type of Device: SPECIAL INSTRUMENTS FOR VEGA SYSTEM
• 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
• MDR Report Key: 7114383
• MDR Text Key: 94935118
• Report Number: 9610612-2017-00614
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NS825R
• Device Catalogue Number: NS825R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/08/2017
• Date Manufacturer Received: 11/22/2017
• 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