MAUDE Adverse Event Report: AESCULAP AG AND CO. KG LOVE-GRUENWALD RONGUP-BITE3X10MM180MM; RONGUER

Model Number FF806R

Device Problem Break (1069)

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

Event Date 06/04/2015

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Break of the working end during surgery.The broken part fell into the pt.The broken part was withdrawn with difficulty.Procedure: disc curettage - the lumbar canal was narrow.Operation time increased more than 15 min.No clinical consequences observed.

Manufacturer Narrative

Mfg site eval: the movable part of the jaw was broken off of the received device.The visual investigation shows, that the instrument was maintained, but not at aesculap technical service.This can be seen by the taped aesculap label and the foreign label "biotech 08/14".Also, the instrument was analyzed by microscope and hardness testing was completed.The analysis of the fracture pattern illustrated a forced fracture.No pores, inclusions or foreign bodies could be found at the point of rapture.The fracture origin as well as the further processing is located in 3.3.Approximately 50% of the fracture surface shows a dark-brown discoloration.This is a hint for a pre-existing crack, which caused crevice corrosion.The fracture surface shows an intergranular appearance.The rivet of the jaw is slightly deformed.The hardness test confirmed the pre-set values.Set point: 42-50 hrc; results: 49, 6 hrc.The breakage can be attributed to the maintenance of the third-party service or during a surgery by overstressing the instrument due to bending or leverage.An indicator of too high leverage is the deformed pin.The pin and instrument surface should be flush.Corrective action.

• Brand Name: LOVE-GRUENWALD RONGUP-BITE3X10MM180MM
• Type of Device: RONGUER
• 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: 4954181
• MDR Text Key: 6636536
• Report Number: 2916714-2015-00611
• 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: 07/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF806R
• Device Catalogue Number: FF806R
• Date Manufacturer Received: 06/17/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other