MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-12-03 for RASP LIBERATOR KNIFE II, 4.75 X 149MM 25-50016 manufactured by Conmed Linvatec.
[32667032]
The involved rasp liberator knife ii is expected but has not yet been received for an evaluation. A follow-up submission will be filed once the device has been received and the evaluation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[32667033]
The user facility reported that the rasp liberator knife ii blade broke during use in a shoulder superior labrum anterior to posterior (slap) repair. The broken portion was retrieved from the shoulder which contributed to a 20-minute delay. As reported, no patient injury occurred and the procedure was completed as intended. There has been no additional information received regarding the patient's latest condition or any indication that a long term adverse effect has occurred.
Patient Sequence No: 1, Text Type: D, B5
[36715196]
The involved rasp liberator knife ii was received for an evaluation on 06-jan-2015. A visual inspection of the returned device verified that the breakage occurred at the tip of the blade. A metallurgist studied the break and noted that the material is strong but brittle. There is no evidence of porosity. It does not appear that the break is related to the material or manufacturing process. The break appears to be the result of misuse of the device. Lot# 250956 was manufactured on 10-mar-2011. This is a reusable manual instrument over 4. 5 years old that is cleaned and sterilized between uses. A two year review of complaint history shows no similar reports for this product. This failure mode is addressed in the fmea, and the safety risk has been found to be acceptable. The ifu provides the following cautions: inspect instruments prior to use to ensure proper function; no loose pins or misalignment, and that the instrument is in good physical condition. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2015-00077 |
| MDR Report Key | 5265108 |
| Report Source | OTHER |
| Date Received | 2015-12-03 |
| Date of Report | 2015-11-10 |
| Date of Event | 2015-10-05 |
| Date Mfgr Received | 2016-01-06 |
| Device Manufacturer Date | 2011-03-10 |
| Date Added to Maude | 2015-12-03 |
| 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 | MS. BRENDA JOHNSON |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995515 |
| Manufacturer G1 | CONMED LINVATEC |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| 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 | 3 |
| Brand Name | RASP LIBERATOR KNIFE II, 4.75 X 149MM |
| Generic Name | RASP |
| Product Code | HTS |
| Date Received | 2015-12-03 |
| Returned To Mfg | 2016-01-06 |
| Catalog Number | 25-50016 |
| Lot Number | 250956 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | 11311 CONCEPT BLVD. LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-03 |