MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-06-28 for LEMPERT BONE RONGEUR CVD 200MM FO451R manufactured by Aesculap Ag.
[149512228]
(b)(4). Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[149512229]
It was reported that there was an issue with the lempert bone rongeur. During a podiatry procedure, the instrument broke after using it to pull articular cartilage out of a joint. The instrument and piece was removed easily; it was noted that piece had not broken off near the patient's surgical incision. There was no patient harm but the malfunction caused a 3 minute surgical delay. Another device was used instead and the case was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00425 |
| MDR Report Key | 8744449 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-06-28 |
| Date of Report | 2019-08-23 |
| Date of Event | 2019-06-04 |
| Date Facility Aware | 2019-06-04 |
| Date Mfgr Received | 2019-08-23 |
| Device Manufacturer Date | 2019-04-03 |
| Date Added to Maude | 2019-06-28 |
| 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, PA 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 | LEMPERT BONE RONGEUR CVD 200MM |
| Generic Name | BASIC INSTRUMENTS |
| Product Code | HTX |
| Date Received | 2019-06-28 |
| Returned To Mfg | 2019-06-11 |
| Model Number | FO451R |
| Catalog Number | FO451R |
| Lot Number | 4510478467 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-06-28 |