MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-11-16 for LOVE-GRUENWALD RONGEURSTR3X10MM180MM FF805R manufactured by Aesculap Ag.
[128287401]
(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.
Patient Sequence No: 1, Text Type: N, H10
[128287402]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00515 |
| MDR Report Key | 8080325 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-11-16 |
| Date of Report | 2018-11-16 |
| Date Facility Aware | 2018-11-05 |
| Date Mfgr Received | 2018-10-25 |
| Device Manufacturer Date | 2018-03-01 |
| Date Added to Maude | 2018-11-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LOVE-GRUENWALD RONGEURSTR3X10MM180MM |
| Generic Name | BONE PUNCHES, RONGEURS |
| Product Code | HTX |
| Date Received | 2018-11-16 |
| Returned To Mfg | 2018-10-31 |
| Model Number | FF805R |
| Catalog Number | FF805R |
| Lot Number | 4509365408 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-16 |