MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06,08 report with the FDA on 2008-11-21 for ARTHRO-KNIFE, 2-SIDE POINT 70-0077-103 manufactured by Conmed Linvatec.
[970371]
The customer reported that during pre-operative testing, when the arthro-knife blade was retracted, it would not fully return into the sheath.
Patient Sequence No: 1, Text Type: D, B5
[8138810]
Investigation results: an investigation confirmed the reported problem. Upon testing of the returned unit, approximately 1 mm of the blade did not retract into the sheath. Disassembly found the loop portion broken at the trigger. Conmed linvatec has initiated a corrective action to address this failure mode. The instructions for use (ifu) informs the user: inspect the knife assembly, including the retractable slide, for damage (e. G. , cracks, dents) prior to use. Do not use if blade does not fully retract. Do not use if any damage is noticed. Prior to withdrawal from the surgical site, visualize the blade tip to be sure it is fully retracted within the sheath. Injury may result. Sheathed arthroscopy knife blade cutting surfaces are very sharp. Do not insert or remove instrument from patient when the blade is extended out of the sheath. Always retract the blade within the sheath prior to insertion or removal of the instrument from the patient. Injury may result.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2008-00350 |
| MDR Report Key | 1243082 |
| Report Source | 00,01,05,06,08 |
| Date Received | 2008-11-21 |
| Date of Report | 2008-11-06 |
| Date of Event | 2008-10-28 |
| Date Mfgr Received | 2008-11-06 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2009-11-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | BEVERLY SCHANNER |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995169 |
| 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 | ARTHRO-KNIFE, 2-SIDE POINT |
| Generic Name | KNIFE, ORTHOPEDIC |
| Product Code | HTS |
| Date Received | 2008-11-21 |
| Returned To Mfg | 2008-11-11 |
| Model Number | NA |
| Catalog Number | 70-0077-103 |
| Lot Number | BBC49678 |
| ID Number | NA |
| Device Expiration Date | 2011-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-11-21 |