MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2017-09-08 for BUDDE HALO RETRACTOR A1040 manufactured by Integra Lifesciences Corporation Oh/usa.
[86591346]
Integra has completed their internal investigation on august 31, 2017. Device history record reviewed for product ida1040 work order (b)(4) / lot 1418227/ serial # (b)(4). A total of 4 were manufactured on 06/06/2016 show no abnormalities related to the reported failure. The devices manufactured during this period passed all required inspection points with no associated mrr? S, variances or rework. No service history is on file for this device. This product is 100% verified and sampling plans do not apply. Trend analysis: a two year look back in the complaint system from 08/30/2015 to 08/30/2017 for this reported failure and or related to "compression " or "ball" for product family (a1040) shows that two additional complaint were received. No new design or manufacturing trends have been identified. This issue will be monitored. Failure analysis: the complaint was partially confirmed as they provided a picture with the compression ball fractured into two pieces. Root cause: unable to determine root cause; the most likely reason could be from tightening the locking screw without having the halo support post in the compression ball. There is a warning in the instruction manual (451a1007) indicating you can damage the assembly by tightening without the post. This issue will be monitored.
Patient Sequence No: 1, Text Type: N, H10
[86591347]
It was reported that there was a fixation ball damage when using the budde? Halo retractor system (a1040). Request for additional information was sent and on 06sep2017, the following was provided by the customer: the product problem was discovered on (b)(6) 2017, before surgery in the hospital sterilize room. The product was not used on the patient. No patient harm, injury, or death alleged. There was no revision/medical intervention required and no delay in surgery reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004608878-2017-00266 |
| MDR Report Key | 6853686 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2017-09-08 |
| Date of Report | 2017-08-21 |
| Date of Event | 2017-08-18 |
| Date Mfgr Received | 2017-08-21 |
| Device Manufacturer Date | 2016-06-06 |
| Date Added to Maude | 2017-09-08 |
| 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 | MS. ANNETTE ORLANDO |
| 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 | 2017-09-08 |
| Catalog Number | A1040 |
| Lot Number | 1418227/164 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-09-08 |