MAUDE Adverse Event Report: AESCULAP AG CASPAR RONGEURSTRSERR 3X12MM18

Model Number FF563R

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).The upper jaw is broken into the patient during a herniated disk intervention.The intervention was successful but there is a delay of procedure.

Manufacturer Narrative

U.S.Reporting agent notified on: (b)(4) 2015.Manufacturing site evaluation: received device has indications of being maintained (serviced) by a non-aesculap provider.Microscopic analysis of the fracture pattern illustrated that the jaw had been broken previously.On both breakage points were recognizable welding seams.There are indications of excessive torsion forces; as the pin is deformed.The pin and the surface of the device should be flush; however, they are not.Based on the info available as well as a result of our investigation of the root cause of the failure is related to the user w/a contributing factor of insufficient maintenance of the device.Corrective/preventive actions: na.

• Brand Name: CASPAR RONGEURSTRSERR 3X12MM18
• Manufacturer (Section D): AESCULAP AG; tuttlingen DE 18532
• Manufacturer (Section G): AESCULAP AG; p.o. box 40; tuttlingen ; GM
• Manufacturer Contact: nicole broyles ; 615 lambert pte. dr.; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4963907
• MDR Text Key: 6319783
• Report Number: 2916714-2015-00650
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF563R
• Device Catalogue Number: FF563R
• Date Manufacturer Received: 03/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1