MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-06-27 for SMOOTH WIRES 71102102 manufactured by Smith & Nephew, Inc..
[3478582]
It was reported that revision surgery was performed on (b)(6) 2013 due to a broken wire between the outside of the left leg and the ring. According to information from the hospital the (b)(6) patient was known to fall.
Patient Sequence No: 1, Text Type: D, B5
[10866685]
.
Patient Sequence No: 1, Text Type: N, H10
[10908838]
An overload fracture may have occurred during the reported falls. Fatigue cracking is caused by the wire bearing cyclic (i. E. Repeated) stresses in excess of the material endurance limit for an extended period of time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2013-00338 |
| MDR Report Key | 3192994 |
| Report Source | 01,07 |
| Date Received | 2013-06-27 |
| Date of Report | 2013-04-08 |
| Date of Event | 2013-03-21 |
| Date Mfgr Received | 2013-04-08 |
| Date Added to Maude | 2013-06-27 |
| 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 | MS. CARLA SAMUELS |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013995076 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMOOTH WIRES |
| Generic Name | WIRE BAY PT CORTICAL 370MM |
| Product Code | DZK |
| Date Received | 2013-06-27 |
| Catalog Number | 71102102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-06-27 |