MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-09 for BUDDE HALO RETRACTOR A1040 manufactured by Integra Lifesciences Corporation Oh/usa.
[31084015]
It was reported that both clamps on one of the customer's new budde halo had cracks on them. The product was not in contact with the patient and there was no patient injury. The event did not lead to a significant increase in surgery time. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[36734953]
Integra has completed their internal investigation on (b)(6) 2015. The investigation included: methods: evaluation of actual device. Review of device history records. Review of complaints history. Results: device history record reviewed for this product id lot code 108822/141 (manufactured on (b)(6) 2014 ) show no abnormalities related to reported incident found. Devices with lot code 108822/141 passed all required inspection points with no mrr? S, variances or rework associated to the devices. A two year look back in trackwise for this reported failure and or related to "cracked " for this product id shows that no additional complaints were received. No new design or manufacturing trends have been identified. Conclusion: root cause is the rusted support bracket, component flaw.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2015-00288 |
| MDR Report Key | 5212438 |
| Date Received | 2015-11-09 |
| Date of Report | 2015-10-15 |
| Date of Event | 2015-10-15 |
| Date Mfgr Received | 2015-12-22 |
| Device Manufacturer Date | 2014-03-25 |
| Date Added to Maude | 2015-11-09 |
| 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 | 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 | 2015-11-09 |
| Returned To Mfg | 2015-11-18 |
| Catalog Number | A1040 |
| Lot Number | 108822 / 141 |
| 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 | 2015-11-09 |