MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-07 for 4.5MM-15MM LIBERATOR KNIFE 25.50014 manufactured by Conmed Corporation.
[137559796]
Examination confirmed the reported problem and found the tip broken off. The broken tip was returned for evaluation and is approximately 0. 335 inches. Broken tip was damaged at the cutting edges. Examination could not find any issues with critical dimensions. 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 2 complaints regarding 2 devices 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; inspect instruments after use to ensure it has not been damaged. Do not use excessive force on instruments to avoid damage or breakage 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
[137559797]
The customer reported that the 25. 50014, 4. 5mm liberator knife broke during a slap repair on (b)(6) 2018. It's reported the " tip part was broken after the surgeon was isolating labrum from humeral head. The broken piece fell inside of a patient's body, but it was removed using grasper. Surgery was completed successfully without an alternate device. " there was no reported patient injury and a 1-minute reported delay of surgery. 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 | 1017294-2019-00008 |
| MDR Report Key | 8318151 |
| Date Received | 2019-02-07 |
| Date of Report | 2019-02-07 |
| Date of Event | 2018-12-27 |
| Date Mfgr Received | 2019-01-15 |
| Device Manufacturer Date | 2018-02-13 |
| Date Added to Maude | 2019-02-07 |
| 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 | 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 | 4.5MM-15MM LIBERATOR KNIFE |
| Generic Name | KNIFE, ORTHOPEDIC |
| Product Code | HTS |
| Date Received | 2019-02-07 |
| Returned To Mfg | 2019-01-31 |
| Model Number | 25.50014 |
| Catalog Number | 25.50014 |
| Lot Number | 45993 |
| 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 | 2019-02-07 |