MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-08 for BUDDE HALO RADIOLUCENT RETRACTOR A1096 manufactured by Integra Lifesciences Corporation Oh/usa.
[28159934]
The unit was broken since the handle was turned too tight. Additional information was received on (b)(6) 2015 with the following: the product problem occurred during a craniotomy for a parietal tumor procedure on (b)(6) 2015. Patient age and gender were not provided. The position of the patient was not modified. There was no patient injury reported. The event led to an increase in surgery time (time for changing the system to use another one)
Patient Sequence No: 1, Text Type: D, B5
[32794029]
Integra has completed their internal investigation on 11/10/2015. The investigation included: methods: evaluation of actual device. Review of device history records. Review of complaints history. Results: (b)(4); the radiolucent retractor system received with booth support clamps and the halo ring apart. The slot at the support clamps is cut out to small for smooth movement of the slide body. The retaining o-ring also deformed and the screw got loosens, because of the pressure. Device history record reviewed for this product id (b)(4) lot code# 144 manufactured on may 01, 2014 (qty (b)(4)) show no abnormalities related to the reported failure. This device passed all required inspection points with no associated mrr? S, variances or rework. A two year lookback in trackwise for this reported failure and or related to "broken unit? For this product id shows that (b)(4) complaints were received including this case. No new design or manufacturing trends have been identified. This issue will be monitored. Conclusion: root cause could not be determined, the slot at the support clamps is cut out to small for smooth movement of the slide body, this lead to the fact that the retaining o-ring got deformed and the screw got loosen, because of the pressure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2015-00264 |
| MDR Report Key | 5136056 |
| Date Received | 2015-10-08 |
| Date of Report | 2015-09-16 |
| Date of Event | 2015-09-09 |
| Date Mfgr Received | 2015-11-10 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2015-10-08 |
| 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 | 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 RADIOLUCENT RETRACTOR |
| Generic Name | RETRACTOR SYSTEMS |
| Product Code | GZT |
| Date Received | 2015-10-08 |
| Returned To Mfg | 2015-09-17 |
| Catalog Number | A1096 |
| 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 | 2015-10-08 |