MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-10 for LOVE-GRUENWALD RONGEURSTR3X10MM180MM FF805R manufactured by Aesculap Ag.
[183099170]
Manufacturing site evaluation: product not available for investigation. Investigation: no product at hand. Batch history review: the traceability of articles without batch management requirement is guaranteed by the production order number, which can be traced over the production period and the corresponding customer (backtrack). In addition, the raw materials, semi-finished parts, etc. Used for the order are documented in the manufacturing history records (dhr - device history records). This ensures the traceability of the internal supply and production chain. Internal traceability is thus guaranteed. Conclusion and root cause: 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. Rationale: as the product is not available for investigation an exact cause cannot be determined at this moment. Based on the information from customer and the knowledge of the product, the root cause of the error is most probably usage related. The failure is described in the relevant risk analysis and in the corresponding ifu. Such breakages are caused by overloading of the mouth part, e. G. By grasping too hard tissue or bones, by using a blunt instrument which causes the need of higher forces and finally results in overloading. Corrective action: according to sop (b)(4) (corrective action & preventive action) a capa is not necessary.
Patient Sequence No: 1, Text Type: N, H10
[183099171]
It was reported that there was an issue with a love-gruenwald rongeur. According to the reporter there was a rupture of the forceps jaw during a l4-l5 discectomy and arthrodesis intervention surgery during disc curettage. Despite several attempts, it was impossible to recover the metal fragment which remained in the patient. Additional information has been requested. Additional patient data is not available. The adverse event is filed under (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2020-00025 |
| MDR Report Key | 9813939 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-03-10 |
| 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 KERSTIN ROTHWEILER |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78501 |
| 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 | 2020-03-10 |
| Model Number | FF805R |
| Catalog Number | FF805R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2020-03-10 |