MAUDE Adverse Event Report: AESCULAP AG AND CO. KG CASPAR RONGEURSTRSERR 3X12MM160MM

Model Number FF533R

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Bite broke during surgery.The incident did occur during surgery and there was a considerable delay of nearly one hour.As to any harm unable to comment on this at present although the rest of the procedure went according to plan.

Manufacturer Narrative

Us reporting agent notified on (b)(4) 2015.Mfg site eval: hardness testing performed.Hardness and material are according to specification.The guidance of the jaw is not parallel, which indicates there was bending of the device.The fracture occurred due to mechanical overload (during bending).

• Brand Name: CASPAR RONGEURSTRSERR 3X12MM160MM
• Type of Device: RONGEUR
• Manufacturer (Section D): AESCULAP AG AND CO. KG; tuttlingen DE 78532
• Manufacturer (Section G): AESCULAP AG AND CO KG; po box 40; tuttlingen 7850 1; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe dr.; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4436272
• MDR Text Key: 5392694
• Report Number: 2916714-2015-00032
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF533R
• Device Catalogue Number: FF533R
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/03/2014
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other