MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-09-30 for KARLIN CRANK FRAME RETRACTOR BODY 46-3191 manufactured by Symmetry Surgical.
[5019437]
Surgeon doing a laminectomy where he was using a codman back retractor. The frame completely seized on the patient in the middle of the procedure. The surgeon, as strong as he is, couldn't get it off. Eventually, after a lot of thinking, mineral oil was used to get it off and they requested a new codman, which we gave.
Patient Sequence No: 1, Text Type: D, B5
[12291243]
Device is currently under review.
Patient Sequence No: 1, Text Type: N, H10
[96241799]
Symmetry surgical is submitting this follow up report: form fda 3500a. Symmetry surgical's initial complaint came in on 09/14/2014, the device 46-3191-karlin crank frame retractor body, the frame completely seized on the patient in the middle of the procedure, there was no harm to the patient. The device 46-3191-karlin crank frame retractor body was sent back to symmetry surgical via rma process on 09/14/2014; symmetry then sent the device to the supplier for evaluation upon return from the end user. The supplier evaluated the device: 46-3191-karlin crank frame retractor body on 11/04/2014, and provided symmetry surgical with the following results: it was not possible to move the right arm on the rack. The pinon is stuck in the housing hole. No lubrication of the pinon drive, lubricate before each use. Based off this conclusion and the instructions for use on reprocessing, lubrication of the moving parts should mitigate this issue going forward. No further action is required at this time. Should you require additional information for this follow up report: 3007208013-2014-00016 #1, please feel free to contact us directly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007208013-2014-00016 |
| MDR Report Key | 4178100 |
| Report Source | 99 |
| Date Received | 2014-09-30 |
| Date of Report | 2014-09-29 |
| Date of Event | 2014-09-12 |
| Date Mfgr Received | 2014-09-17 |
| Date Added to Maude | 2014-10-30 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRIS SMITH |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARLIN CRANK FRAME RETRACTOR BODY |
| Generic Name | CRANK FRAME RETRACTOR BODY |
| Product Code | GZT |
| Date Received | 2014-09-30 |
| Model Number | 46-3191 |
| Catalog Number | 46-3191 |
| Lot Number | NA |
| ID Number | 00887482014950 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL |
| Manufacturer Address | 3034 OWEN DRIVE ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-30 |