MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-23 for PETIT-POINT MIXTER FCPS 7-1/4 140223 manufactured by Hebumedical Gmbh.
[46857896]
Per complaint files of the last three years, no similar issues were recorded for this device. The probable root cause is inappropriate use. As per event description the clamp was used for a traction and reduction maneuver during a percutaneous pinning operation. The petit-point-mixter fcps 7-1/4 is intended for use as a vascular clamp. Its delicate tips are not designed for traction maneuvers with high tension forces.
Patient Sequence No: 1, Text Type: N, H10
[46857897]
As per importer report # (b)(4): a piece of the instrument broke off in the patient's foot during surgery. (b)(6) 2015 customer reported that on (b)(6) 2015 a left foot percutaneous pinning of numbers 3,4 and 5 metatarsals was performed. During a traction and reduction maneuver the tip of one of the arms of the clamp broke off and lodged deep in the soft tissue. Multiple attempts made with fluoroscopy, ap lateral and obliques were fruitless to find broken piece, given the size of the foot due to swelling and the depth of the incision. Post op visits on (b)(6) 2015 indicate progressive healing. (b)(6) 2015 x-ray shows small metal fragment. Healing as expected, no issues related to the metal fragment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002806609-2016-00009 |
| MDR Report Key | 5672309 |
| Date Received | 2016-05-23 |
| Date of Report | 2016-05-20 |
| Date of Event | 2015-02-18 |
| Date Mfgr Received | 2015-12-08 |
| Date Added to Maude | 2016-05-23 |
| 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 | MR. THOMAS BUTSCH |
| Manufacturer Street | BADSTRASSE 8 |
| Manufacturer City | TUTTLINGEN, 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78532 |
| Manufacturer Phone | 46194710 |
| Manufacturer G1 | HEBUMEDICAL GMBH |
| Manufacturer Street | BADSTRASSE 8 |
| Manufacturer City | TUTTLINGEN, 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PETIT-POINT MIXTER FCPS 7-1/4 |
| Generic Name | HEMOSTAT |
| Product Code | HRQ |
| Date Received | 2016-05-23 |
| Catalog Number | 140223 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEBUMEDICAL GMBH |
| Manufacturer Address | BADSTRASSE 8 TUTTLINGEN, 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-23 |