MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-19 for STABLELOC EXTERNAL FIXATOR KIT FX-4001-S manufactured by Acumed Llc.
[45576463]
Evaluation of the returned product found that there was a driver tip broken off in the set screw. (this occurred during the removal surgery when it broke trying to loosen the set screw. ) the set screw was unscrewed by hand - there was no evidence of binding between the screw and the housing. There was also no evidence of cross threading or deformation. All of the parts of the returned device were found to be in spec.
Patient Sequence No: 1, Text Type: N, H10
[45576464]
The surgeon put a stableloc external fixator on a comminuted distal radius fracture on (b)(6) 2016. On (b)(6) 2016, the patient was seen for removal. The surgeon could not loosen the set screw to remove it; a driver tip was broken off in the screw head. The patient was brought to the surgery center for removal the next day and was placed under anesthesia. The surgeon used pliers to loosen the screw and remove the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3025141-2016-00127 |
| MDR Report Key | 5668058 |
| Date Received | 2016-05-19 |
| Date of Report | 2016-05-09 |
| Date of Event | 2016-04-27 |
| Date Mfgr Received | 2016-05-09 |
| Device Manufacturer Date | 2013-11-11 |
| Date Added to Maude | 2016-05-19 |
| 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. MICKI LEHMAN |
| Manufacturer Street | 5885 NW CORNELIUS PASS ROAD |
| Manufacturer City | HILLSBORO OR 971249432 |
| Manufacturer Country | US |
| Manufacturer Postal | 971249432 |
| Manufacturer Phone | 5036279957 |
| Manufacturer G1 | ACUMED LLC |
| Manufacturer Street | 5885 NW CORNELIUS PASS ROAD |
| Manufacturer City | HILLSBORO OR 971249432 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 971249432 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STABLELOC EXTERNAL FIXATOR KIT |
| Generic Name | COMPONENT, TRACTION, INVASIVE |
| Product Code | JEC |
| Date Received | 2016-05-19 |
| Returned To Mfg | 2016-05-13 |
| Model Number | FX-4001-S |
| Catalog Number | FX-4001-S |
| Lot Number | 313110 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACUMED LLC |
| Manufacturer Address | 5885 NW CORNELIUS PASS ROAD HILLSBORO OR 971249432 US 971249432 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-05-19 |