MAUDE Adverse Event Report: AESCULAP AG & CO. KG ROETTGEN-RUSKIN BONE RONGEUR 2; BONE CUTTER

Model Number FO521R

Device Problem Device Dislodged or Dislocated (2923)

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

Event Type  malfunction  

Event Description

Country of complaint: (b)(4).Screw came loose during surgery and fell into patient.Screw was retrieved, surgery delay greater than 15 minutes.No harm to patient.

Manufacturer Narrative

U.S.Reporting agent notified on: (b)(6) 2015.Manufacturing site investigation: device received for evaluation with one of the screws in the joint position missing.Instruments was in a dry condition-no lubrication present.The device was manufactured in (b)(4) 2014 and looks heavily used.The jaw shows notches and the blade and the surface contains deep scratching it has determined that heavy use, along with inadequate lubrication resulted in a loosening of the screw.No manufacturing a material defects were found.

• Brand Name: ROETTGEN-RUSKIN BONE RONGEUR 2
• Type of Device: BONE CUTTER
• Manufacturer (Section D): AESCULAP AG & CO. KG; tuttlingen, de 7853 2
• Manufacturer (Section G): AESCULAP AG&CO KG; po box 40; tuttlingen 7850 1; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4795736
• MDR Text Key: 5858845
• Report Number: 2916714-2015-00440
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FO521R
• Device Catalogue Number: FO521R
• Date Manufacturer Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other