MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-10 for TENZOR CARBON FIBER TRACTION UNIT ASSEMBLY manufactured by Steris Corporation - Montgomery.
[40337773]
A steris account manager arrived onsite, inspected the assembly, and identified that the boot straps ripped/tore. It is most likely that the or staff over tightened the straps causing them to rip/tear. The account manager replaced the boot straps, tested the assembly, and confirmed it to be operating according to specification. The assembly was returned for customer use. No additional issues have been reported. Section 1 of the operator manual for the tenzor carbon fiber traction unit assembly states, "check the table orthopedic extension abductor bars, siderails and carbon fiber traction unit for possible damage or wear prior to each use. Do not use the carbon fiber traction unit if any damage is apparent, if parts are missing or if it does not operate as expected. "
Patient Sequence No: 1, Text Type: N, H10
[40337774]
The user facility reported that the boot strap on their tenzor carbon fiber traction unit assembly broke during a patient procedure. No report of injury, however the procedure was delayed due to the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043572-2016-00021 |
| MDR Report Key | 5492569 |
| Date Received | 2016-03-10 |
| Date of Report | 2016-03-10 |
| Date of Event | 2016-02-15 |
| Date Mfgr Received | 2016-02-15 |
| Date Added to Maude | 2016-03-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927231 |
| Manufacturer G1 | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Street | 2720 GUNTER PARK DRIVE EAST |
| Manufacturer City | MONTGOMERY AL 36109 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 36109 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TENZOR CARBON FIBER TRACTION UNIT ASSEMBLY |
| Generic Name | SURGICAL TABLE ACCESSORY |
| Product Code | JEB |
| Date Received | 2016-03-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Address | 2720 GUNTER PARK DRIVE EAST MONTGOMERY AL 36109 US 36109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-10 |