MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-16 for HOLDER LEG 012310 manufactured by Smith & Nephew, Inc..
[75404088]
One leg holder was returned for evaluation. Visual assessment of the device shows it is well worn. There is damage to the pads and their assemblies. The positioning locks threads are stripped. The plating is coming off of the lateral pad lock assembly. A machine screw has been placed in the lateral pad lock assembly. The device is in need of complete refurbishment and likely did at the time of this incident. We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced or repaired as necessary. No root cause related to the manufacture of the device can be established. No further investigation is warranted at this time.
Patient Sequence No: 1, Text Type: N, H10
[75404089]
It was reported that during the procedure the pin will not keep the leg locked. A back up device of the same kind was available to continue the procedure. No patient harm was reported. The leg was able to shift/rotate but it is unknown if traction was lost.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-2017-00495 |
| MDR Report Key | 6571146 |
| Date Received | 2017-05-16 |
| Date of Report | 2017-05-16 |
| Date of Event | 2017-04-03 |
| Date Mfgr Received | 2017-04-03 |
| Date Added to Maude | 2017-05-16 |
| 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. JAMES GONZALES |
| Manufacturer Street | 7000 W. WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 76 S. MERIDIAN AVE. |
| Manufacturer City | OKLAHOMA CITY OK 731076512 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 731076512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HOLDER LEG |
| Generic Name | RESTRAINT, PATIENT, CONDUCTIVE |
| Product Code | BRT |
| Date Received | 2017-05-16 |
| Returned To Mfg | 2017-05-09 |
| Catalog Number | 012310 |
| Lot Number | EPO |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 76 S. MERIDIAN AVE. OKLAHOMA CITY OK 731076512 US 731076512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-16 |