MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-16 for BUDDE HALO RETRACTOR A1040 manufactured by Integra Lifesciences Corporation Oh/usa.
[34358153]
When the knob of the retractor arm was fastened, the multi strand cable was broken. The product problem was discovered during inspection of the device. There was no patient contact.
Patient Sequence No: 1, Text Type: D, B5
[41624942]
Integra has completed their internal investigation on 02/01/2016. The investigation included: methods: evaluation of actual device. Review of device history records. Review of complaint history. The cable of retractor arm was broken. The device in question was manufactured on september 30, 2006. A two year review of complaints history for this reported failure and or related to "arm is broken " for this product id shows that 3 complaints were received including this case. No new design or manufacturing trends have been identified. In summary the end users reason for return was verified however the root cause can not be determined at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2015-00308 |
| MDR Report Key | 5304323 |
| Date Received | 2015-12-16 |
| Date of Report | 2015-11-25 |
| Date of Event | 2015-11-25 |
| Date Mfgr Received | 2016-02-01 |
| Device Manufacturer Date | 2006-09-30 |
| Date Added to Maude | 2015-12-16 |
| 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 | MRS. ROWENA BUNUAN |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Street | 4900 CHARLEMAR DRIVE |
| Manufacturer City | CINCINNATI OH 45227 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUDDE HALO RETRACTOR |
| Generic Name | RETRACTOR SYSTEMS |
| Product Code | GZT |
| Date Received | 2015-12-16 |
| Returned To Mfg | 2015-11-27 |
| Catalog Number | A1040 |
| Lot Number | 067/CHN052_01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Address | 4900 CHARLEMAR DRIVE 4900 CHARLEMAR DRIVE CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-16 |