MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-06-18 for GUIDE WIRE 430165 manufactured by Aap Implantate Ag.
[3519464]
Guide wire for cannulated screw broke off during surgery. It broke off when doctor was flexing the joint checking to see if joint was secure. There was a pop and the k-wire broke. After k-wire broke doctor took an x-ray to see where the remaining piece was in the foot. Doctor decided to leave the piece in the pt. Remaining k-wire was discarded by surgeon.
Patient Sequence No: 1, Text Type: D, B5
[10756063]
It was not possible for the sales rep of our distributor to receive a surgery report or any x-rays for eval. The review of the device history record showed no deviation from the specification. The sales rep wrote that the surgeon did not use the obturator (drill guide for guide wires) as written and requested in the surgery technique. This obturator avoids bending forces which could arise when the guide wires touches the periost. Therefore, it seems that the breakage occurred because the user did not follow the instructions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043862-2013-00004 |
| MDR Report Key | 3185075 |
| Report Source | 08 |
| Date Received | 2013-06-18 |
| Date of Report | 2013-06-18 |
| Date Mfgr Received | 2013-05-21 |
| Device Manufacturer Date | 2011-12-30 |
| Date Added to Maude | 2013-09-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARC SEEGERS |
| Manufacturer Street | LORENZWEG 5 |
| Manufacturer City | BERLIN 12099 |
| Manufacturer Country | GM |
| Manufacturer Postal | 12099 |
| Manufacturer Phone | 9307501919 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GUIDE WIRE |
| Generic Name | K-WIRE |
| Product Code | GFC |
| Date Received | 2013-06-18 |
| Catalog Number | 430165 |
| Lot Number | QR0001 OR QR0002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AAP IMPLANTATE AG |
| Manufacturer Address | LORENZWEG 5 BERLIN 12009 GM 12009 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-06-18 |