MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-03-12 for COLLINS RADIOPARENT BLADE 50-8081 manufactured by Codman And Shurtleff - Raynham.
[9859336]
Upon completion of the investigation it was noted that the supplier performed this investigation and during the evaluation process it was found that many used and unused blades were tested and none of which could be broken as described by the customer. It is not possible to determine the exact root cause; however it might be likely that the blades were mis-used. The supplier performed additional testing on the blades to try and determine the actual force needed to break a blade. It was only possible to break a blade when the blade was inserted into the actual metal device at an approximate 30 degree angle. Pressure was applied until the blade broke. The calculation of force required to break the blade was in excess of 250kg, far above the codman specification of 60kg. It was also noted that the blades returned from the customer showed evidence of distortion on one of two key retaining tabs. We suspect the only way this tab can be distorted, is for the blade to be cocked at angle. As a result it is likely that the blade was mis-used.
Patient Sequence No: 1, Text Type: N, H10
[10006192]
This device is a reusable product.
Patient Sequence No: 1, Text Type: N, H10
[15508468]
Affiliate reported that the when the blades were inserted into the retractor body and spread with minor force one of the two blades broke in pieces, the sternum closed suddenly. Affiliate also reported the texture of the blades appeared to be different.
Patient Sequence No: 1, Text Type: D, B5
[15753616]
Upon completion of the investigation a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[34909394]
We recently revised our mdr reporting procedures based on feedback from a recent fda audit that was conducted in 2013. Once the changes were made to the procedures, we conducted retrospective review of our product complaints and mdr files. The attached mdr report is being filed as result of those changes we made to our internal mdr reporting procedures. Please refer to complaint (b)(4). A follow-up is being generated changing in the medwatch to an adverse event.
Patient Sequence No: 1, Text Type: N, H10
[34909395]
The blades were inserted into the retractor body. When or-team started to spread (with a minor force) one of the two blades broke to pieces, the sternum closed suddenly. The patient as well as the surgeon were profoundly endangered. Affiliate also reported that the texture of the blades seems to be different since the color change to grey some time ago. We recently revised our mdr reporting procedures based on feedback from a recent fda audit that was conducted in 2013. Once the changes were made to the procedures, we conducted retrospective review of our product complaints and mdr files. The attached mdr report is being filed as result of those changes we made to our internal mdr reporting procedures. Please refer to complaint (b)(4). A follow-up is being generated changing in the medwatch to an adverse event.
Patient Sequence No: 1, Text Type: D, B5
[34909685]
We recently revised our mdr reporting procedures based on feedback from a recent fda audit that was conducted in 2013. Once the changes were made to the procedures, we conducted retrospective review of our product complaints and mdr files. The attached mdr report is being filed as result of those changes we made to our internal mdr reporting procedures. Please refer to complaint (b)(4). A follow-up is being generated changing in the medwatch to an adverse event.
Patient Sequence No: 1, Text Type: N, H10
[34909686]
The blades were inserted into the retractor body. When or-team started to spread (with a minor force) one of the two blades broke to pieces, the sternum closed suddenly. The patient as well as the surgeon were profoundly endangered. Affiliate also reported that the texture of the blades seems to be different since the color change to grey some time ago. We recently revised our mdr reporting procedures based on feedback from a recent fda audit that was conducted in 2013. Once the changes were made to the procedures, we conducted retrospective review of our product complaints and mdr files. The attached mdr report is being filed as result of those changes we made to our internal mdr reporting procedures. Please refer to complaint (b)(4). A follow-up is being generated changing in the medwatch to an adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2012-00124 |
| MDR Report Key | 2488486 |
| Report Source | 01,07 |
| Date Received | 2012-03-12 |
| Date of Event | 2012-02-13 |
| Date Mfgr Received | 2014-05-14 |
| Date Added to Maude | 2012-03-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLLINS RADIOPARENT BLADE |
| Generic Name | BLADE, SAW, SURGICAL, CARDIOVASCULAR |
| Product Code | DWH |
| Date Received | 2012-03-12 |
| Returned To Mfg | 2012-03-07 |
| Catalog Number | 50-8081 |
| Lot Number | 123831 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN AND SHURTLEFF - RAYNHAM |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-03-12 |