MAUDE Adverse Event Report: AESCULAP AG LOVE-GRUENWALD RONGEURSTR3X10MM180MM; BONE PUNCHES, RONGEURS

Model Number FF805R

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The moveable jaw part of the instrument is broken off missing.Staining can be found all over the surface of the instrument.The uneven pins are indicators of an overload situation by leverage.No pores, inclusions or foreign bodies can be found on the point of rupture of the pins.Furthermore a damage of the blade can be found, most likely caused by hard tissue like bones.Extract of the ifu: intended use: the rongeurs are used for the ablation of soft tissue (e.G.Intervertebral disk tissue, mucosa, ethmoidal cells, cell tissue, nucleus tissue, sequester material) in neurosurgery and spine surgery.The rongeurs cannot be used for the ablation of bones or adjacent bone structures, for which purpose aesculap recommends using bone punches, because of their higher mechanical load capacity.The device quality and manufacturing history records have been checked for the available lot number and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.Based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage.The uneven pins and the damaged blade are indicators for an off label usage.According to the ifu, rongeurs cannot be used for the ablation of bones or adjacent bone structures, but for the ablation of soft tissue.A capa is not necessary.

Event Description

It was reported by the healthcare professional "the tip broke off while removing the disc material from an anterior approach to the cervical spine." the tip was part of the movable jaw on a rongeur.No harm to the patient reported.The surgeon used a different sized rongeur to proceed with the operation.Surgical procedure: anterior cervical discectomy and fusion.

• Brand Name: LOVE-GRUENWALD RONGEURSTR3X10MM180MM
• Type of Device: BONE PUNCHES, RONGEURS
• 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: 8080325
• MDR Text Key: 128287401
• Report Number: 9610612-2018-00515
• 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,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF805R
• Device Catalogue Number: FF805R
• Device Lot Number: 4509365408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/05/2018
• Device Age: 8 MO
• Date Manufacturer Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1