MAUDE Adverse Event Report: AESCULAP AG CUSHING RONGEUR STR 2X10MM180MM

Model Number FF803R

Device Problem Fracture (1260)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).Jaw broke during use; in the patient.Practitioner used another instrument for removal.

Manufacturer Narrative

The instrument was analyzed by microscope.The analysis of the fracture pattern illustrated a forced fracture due to overload.The visible damages on both parts of the jaw also confirm the overload situation.No pores, inclusions or foreign bodies could be found.The brushed surface indicates that the instrument was maintained.The device quality and manufacturing history records is not possible.Based on the information available as well as a result of the investigation, root cause of the failure is most probably user related.The breakage of the device maybe the result of maintenance of the third-party service, or surgery by overstressing the instrument due to bending or leverage.The current failure is within the risk analysis and therefore acceptable.

• Brand Name: CUSHING RONGEUR STR 2X10MM180MM
• Type of Device: RONGEUR
• 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: 5411461
• MDR Text Key: 37527350
• Report Number: 2916714-2016-00083
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FF803R
• Device Catalogue Number: FF803R
• Device Lot Number: 4505079764
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/30/2015
• Device Age: 3 YR
• Date Manufacturer Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other