MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-28 for TC NEEDLE HOLDER X-DEL SERR200MM BM026R manufactured by Aesculap Ag.
[30219563]
Manufacturing site evaluation: on-going.
Patient Sequence No: 1, Text Type: N, H10
[30219564]
Device broke during a hip fracture. An x-ray was performed and found to be negative for retained piece. No patient injury; surgery delay 10-15 minutes.
Patient Sequence No: 1, Text Type: D, B5
[36597115]
(b)(4). Manufacturing site evaluation: one of the hard metal inlays of the received instrument was broken 2 mm from the tip. The solder is partially dissolved. Investigation was completed visually, using digital microscope keyence vhx-600. The breakage is user/maintenance related. The breakage appears to have resulted from a needle slipping off the needle holder. Aggressive maintenance methods can result in dissolving of the solder, causing the carbide metal to become brittle. Corrective/preventive action is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-00989 |
| MDR Report Key | 5183931 |
| Date Received | 2015-10-28 |
| Date of Report | 2016-01-21 |
| Date Mfgr Received | 2015-09-28 |
| Date Added to Maude | 2015-10-28 |
| 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 |
| 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 | 3 |
| Brand Name | TC NEEDLE HOLDER X-DEL SERR200MM |
| Generic Name | NEEDLE HOLDER |
| Product Code | HXK |
| Date Received | 2015-10-28 |
| Model Number | BM026R |
| Catalog Number | BM026R |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-10-28 |