MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-07-12 for BUDDE HALO RADIOLUCENT RETRACTOR A1096 manufactured by Integra Lifesciences Corporation Oh/usa.
[49251405]
Integra has completed their internal investigation on 28 jun 2016. The investigation included: methods: evaluation of actual device; review of device history records; review of complaint history. Results: evaluation of device: engineering was able to confirm the customer complaint. The support clamp, 443a1060m, had a fracture in its component, the clamp slide body, 443a1062. A dhr review could not be performed as no integra lot# was etched on the component received and the serial# etched on the a1096 is not an integra lot#. A two year lookback in trackwise for this reported failure and or related to " broken part " for product id 40a1096 and 443a1060 shows that no additional complaints were received. No new design or manufacturing trends have been identified. This issue will be monitored. In summary: engineering was able to verify the customer complaint of the breakage. The root cause cannot be fully attributed at this time. It may have seemed that the breakage occurred from a physical impact exerted onto the component during use/processing.
Patient Sequence No: 1, Text Type: N, H10
[49251406]
The a1096 budde halo retractor had a broken part. The rod holder clamp was broken. The device was properly assembled by the company's sales representative, however the part broke when the a2114 was assembled with it. The device not in contact with patient, there was no patient injured or death alleged and it did not lead to an increase of surgery time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004608878-2016-00181 |
| MDR Report Key | 5784966 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-07-12 |
| Date of Report | 2016-04-28 |
| Date Mfgr Received | 2016-06-28 |
| Date Added to Maude | 2016-07-12 |
| 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 | USER BINA PATEL |
| 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 RADIOLUCENT RETRACTOR |
| Generic Name | RETRACTOR SYSTEMS |
| Product Code | GZT |
| Date Received | 2016-07-12 |
| Returned To Mfg | 2016-05-02 |
| Catalog Number | A1096 |
| Lot Number | RLU0500 |
| Device Availability | R |
| 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 | 2016-07-12 |