MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-08-13 for TC MAYO-HEGAR NDL HOLDERHVYSERR185MM BM066R manufactured by Aesculap Ag & Co. Kg.
[25060588]
Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[25060589]
Facility reports the device broke during surgery and a piece was lost inside the patient.
Patient Sequence No: 1, Text Type: D, B5
[35883601]
Manufacturing site evaluation: product received with one of the hard metal inlays is broken 2 mm from the tip. Investigation was completed visually, using the digital microscope. This failure is user/maintenance related. The tip of the carbide metal may have broken off due to a needle being picked up and it slipped off the needle holder or by aggressive maintenance methods, the solder area may have dissolved, resulting in the carbide metal being brittle. Corrective / preventive action(s): not applicable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-00751 |
| MDR Report Key | 5046424 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-08-13 |
| Date of Report | 2016-01-13 |
| Date Mfgr Received | 2015-07-24 |
| Date Added to Maude | 2015-09-01 |
| 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 | 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&CO KG |
| 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 | TC MAYO-HEGAR NDL HOLDERHVYSERR185MM |
| Generic Name | NEEDLE HOLDER |
| Product Code | HXK |
| Date Received | 2015-08-13 |
| Model Number | BM066R |
| Catalog Number | BM066R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG & CO. KG |
| Manufacturer Address | TUTTLINGEN DE 78532 DE 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-13 |