MAUDE Adverse Event Report: AESCULAP AG RUSKIN BONE RONGEUR CVD 190MM; ONE RONGEURS AND BONE CUTTING FORC

Model Number FO518R

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).It was reported that during a knee-tep implantation: a screw loosened unnoticed and fall in the wound area of the patient.X-rays was performed during the or, screw was located.Immediate revision was performed.

Manufacturer Narrative

Investigation: the instrument was lost in transit.Conclusion and root cause: without the product a root cause analysis is not possible.Rational: based on the quality standards we exclude a material or manufacturer caused error.No capa is necessary.

• Brand Name: RUSKIN BONE RONGEUR CVD 190MM
• Type of Device: ONE RONGEURS AND BONE CUTTING FORC
• Manufacturer (Section D): AESCULAP AG; 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: 6821022
• MDR Text Key: 83671086
• Report Number: 9610612-2017-00446
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• 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: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FO518R
• Device Catalogue Number: FO518R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/24/2017
• Date Manufacturer Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR