MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-28 for POSITIONER SPIDER LIMB 7210569 manufactured by Smith & Nephew, Inc..
[87750569]
The device was received for evaluation. There was a relationship found between the returned device and the reported incident. A visual inspection was performed on the product and no issues were observed. A functional evaluation revealed the device had an air leak in the swivel. The complaint was confirmed and a root cause identified to be an air leak associated with a mechanical component failure. Pneumatic swivel joints can develop a minor seal leak if impacted or may? Unseat? During certain swivel movements but will generally reseat upon manipulation.
Patient Sequence No: 1, Text Type: N, H10
[87750570]
It was reported that during the rotator cuff repair, it was noticed that the device was leaking air and not holding. There was a delay in the procedure less than thirty minutes. A back-up device was available. No reported patient injuries and complications were noted.
Patient Sequence No: 1, Text Type: D, B5
[117304990]
Providing updated information received. Correcting the device common name and procode. Based on review of the new information received, the event is no longer considered reportable.
Patient Sequence No: 1, Text Type: N, H10
[117304991]
Traction was not lost and the procedure was completed using the same device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1643264-2017-00586 |
| MDR Report Key | 6901104 |
| Date Received | 2017-09-28 |
| Date of Report | 2017-10-09 |
| Date of Event | 2017-04-07 |
| Date Mfgr Received | 2017-10-05 |
| Date Added to Maude | 2017-09-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | JIM 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 | POSITIONER SPIDER LIMB |
| Generic Name | INCUBATOR, NEONATAL |
| Product Code | FMZ |
| Date Received | 2017-09-28 |
| Returned To Mfg | 2017-04-25 |
| Model Number | 7210569 |
| Catalog Number | 7210569 |
| 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 | 2017-09-28 |