MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-07 for SMARTSTITCH PP CONNECTOR OM-8010 manufactured by Arthrocare Corp..
[35344368]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[35344369]
It was alleged the smartstitch perfect passer connector did not deploy suture through the cuff and caused a 1mm tear to the cuff during surgery.
Patient Sequence No: 1, Text Type: D, B5
[37859409]
Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation. Thus, the customer? S complaint could not be verified, nor could a root cause be determined with confidence. Potential factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: tissue thickness, incorrect suture cartridge attachment, incomplete travel of needle drive lever. Tissue thickness or incomplete activation of the needle driver lever can result in suture not deploying through the cuff. The instruction for use (? Ifu? ) were reviewed and were found to provide clear and thorough instructions for use and outlines warnings and precautionary measures when using the device such as: always actuate the suturing device without a suture cartridge prior to clinical use. This will ensure that the clamp jaw lever, connector release lever, and needle driver lever are functioning properly. Ensure that the suture cartridge is locked to the distal tip of the suturing device. Tug gently but firmly to assure secure placement. If the suture cartridge does not properly engage, remove and replace the suture cartridge. Do not use or effect a repair using the suturing device if proposed tissue is not viable. There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.
Patient Sequence No: 1, Text Type: N, H10
[44792621]
Visual inspection of the device found that connector was received with a suture cartridge attached. The needles were fired, but they could not be retracted. During functional testing, the suture cartridge was removed and the device was reloaded with a new cartridge. The needles were fired, but the issue of the needle not retracting persisted. The device was disassembled and found that the s-coupling material was broken with jagged edges observed near the break point. The root cause for the broken s-coupling material could not be determined with confidence. Factors unrelated to the manufacturing or design of the device that could have contributed to the reported event includes excessive force of the device or incomplete set-up/use of the device. The instruction for use (ifu) outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality. There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006524618-2016-00009 |
| MDR Report Key | 5352414 |
| Date Received | 2016-01-07 |
| Date of Report | 2016-05-06 |
| Date of Event | 2015-09-16 |
| Date Mfgr Received | 2015-12-15 |
| Date Added to Maude | 2016-01-07 |
| 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 | JIM GONZALES |
| Manufacturer Street | 7000 W. WILLIAM CANNON DR. |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123585706 |
| Manufacturer G1 | ARTHROCARE CORP. |
| Manufacturer Street | 7000 W. WILLIAM CANNON |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78735 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTSTITCH PP CONNECTOR |
| Generic Name | RETENTION DEVICE, SUTURE |
| Product Code | KGS |
| Date Received | 2016-01-07 |
| Returned To Mfg | 2016-03-23 |
| Catalog Number | OM-8010 |
| Lot Number | 1057053 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROCARE CORP. |
| Manufacturer Address | 7000 W. WILLIAM CANNON AUSTIN TX 78735 US 78735 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-07 |