MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-23 for METHA ?CAP 12/14 130?/0? SIZE 1 NC271T manufactured by Aesculap Implant Systems.
[75859659]
(b)(4). Manufacturing site evaluation: evaluation on-going. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[75859660]
Country of complaint: (b)(6). It was reported that about 5 years later, the patient has a problem with osteolysis so there is loosening on both sides of the knee. No revision surgery has been scheduled. All med watch submissions related to this report are: 9610612-2017-00293, 9610612-2017-00294.
Patient Sequence No: 1, Text Type: D, B5
[114851106]
Investigation: the components have been examined visually and microscopically with a keyence vhx-5000 digital microscope. The breakage surface of both devices shows a transgranular forced fracture. The direction of the breakage is from outside to the inside. The broken pieces are not available. Batch history review: the product does not require batch management; a review of the device quality and manufacturing history records is not possible. 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 user related. Rational: this type of damage indicates an user related error. We assume that the device was hammered in too hard and therefore mechanically overloaded. Corrective action. According to sop sa-de13-m-4-2-01-010 a capa is not necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610612-2017-00293 |
| MDR Report Key | 6585277 |
| Date Received | 2017-05-23 |
| Date of Report | 2017-07-31 |
| Date of Event | 2017-01-21 |
| Date Facility Aware | 2017-05-18 |
| Date Mfgr Received | 2017-01-21 |
| Date Added to Maude | 2017-05-23 |
| 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 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 | 0 |
| Brand Name | METHA ?CAP 12/14 130?/0? SIZE 1 |
| Generic Name | IMPLANTS METHA |
| Product Code | HSA |
| Date Received | 2017-05-23 |
| Model Number | NC271T |
| Catalog Number | NC271T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP IMPLANT SYSTEMS |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-23 |