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 2018-06-25 for RONGEUR WAGNERHEAVY PATTERN STR200MM FF818R manufactured by Aesculap Ag.
[112453536]
(b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[112453537]
Country of complaint: (b)(6). During maintenance after an operation, the customer found that motion of working end was defective and a hole for rivet/pin was seen. However, rivet/pin was missing.
Patient Sequence No: 1, Text Type: D, B5
[119254488]
Investigation: the investigation was performed using a keyence vhx-5000 digital microscope. The pin is broken, but the fragment is not available for investigation. The manufacturing date is not longer comprehensible, the last maintenance of the instrument was carried out in march 2007. Deposits can be found all over the surface, caused by an insufficient reprocessing. The blade of the lower part is damaged, most likely caused by grasping a hard object. 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. Rational: in correlation with the old age of the instrument and the damaged blade, the breakage of the pin was most likely caused by high operating force during application. No capa is necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610612-2018-00239 |
| MDR Report Key | 7635756 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-25 |
| Date of Report | 2018-08-08 |
| Date of Event | 2018-05-21 |
| Date Facility Aware | 2018-06-06 |
| Date Mfgr Received | 2018-05-28 |
| Date Added to Maude | 2018-06-25 |
| 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 |
| 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 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 | RONGEUR WAGNERHEAVY PATTERN STR200MM |
| Generic Name | RONGEURS |
| Product Code | HTX |
| Date Received | 2018-06-25 |
| Returned To Mfg | 2018-06-05 |
| Model Number | FF818R |
| Catalog Number | FF818R |
| 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 | 1. Other | 2018-06-25 |