MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-26 for RASP LIBERATOR KNIFE II, 4.75X149MM 25.50016 manufactured by Conmed Corporation.
[139998994]
Complaint is confirmed. Evaluation found the tip of the rasp liberator knife broken off. The broken piece was returned for evaluation and is approximately 0. 340 inches long. Also found damage on the handle end. Inspection was performed and could not find any discrepancies with critical dimensions. This is a technique-dependent device and the most likely cause of this failure is user-related. Suspect that excessive force was used that caused the tip of the rasp liberator knife to break off and suspect that the device was dropped during use due to damage of the handle. The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product. The product released for distribution were found to have met all specifications prior to shipment. This is the only complaint for this lot number and failure mode within the past two years. A two-year review of complaint history revealed there has been 1 complaint regarding 1 device for this device family and failure mode. During the same time frame (b)(4) devices have been manufactured and shipped worldwide. Should all the complaint devices have been found confirmed, the rate of failure would be (b)(4). Per the instructions for use, the user is advised the following; not to use excessive force on instruments to avoid damage during use. Avoid unintended contact with other surgical instruments during use to prevent damage or breakage. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[139998995]
The customer reported the 25. 50016, liberator rasp, broke during a bankart procedure. The tip was retrieved from the patient using arthroscopic graspers. The surgery was completed as planned. There was a delay in surgery, though the delay time was not reported. The procedure was completed using another rasp. Pictures were provided of the broken instrument. This report is being raised based on device malfunction with potential for injury upon reoccurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2019-00033 |
| MDR Report Key | 8453541 |
| Date Received | 2019-03-26 |
| Date of Report | 2019-03-26 |
| Date Mfgr Received | 2019-02-27 |
| Device Manufacturer Date | 2018-12-20 |
| Date Added to Maude | 2019-03-26 |
| 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 | MELANIE HANSEN |
| Manufacturer Street | 11311 CONCEPT BOULEVARD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995209 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 11311 CONCEPT BOULEVARD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RASP LIBERATOR KNIFE II, 4.75X149MM |
| Generic Name | ARTHROSCOPIC RASP |
| Product Code | HTR |
| Date Received | 2019-03-26 |
| Returned To Mfg | 2019-03-08 |
| Model Number | 25.50016 |
| Catalog Number | 25.50016 |
| Lot Number | 986015 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 11311 CONCEPT BOULEVARD LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-26 |