MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-27 for Y-KNOT RC DISPOSABLE DRILL BIT, 2.8MM Y28D manufactured by Conmed.
[112885641]
The device was not returned by the user facility and no photographic evidence was provided; therefore, the reported failure could not be verified and a root cause cannot be conclusively determined. A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications. Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified at the time of manufacture. A review of this lot number showed no other complaint for this lot product and event description. A two-year review of complaint history revealed no other adverse events for this product family and failure mode. In that same timeframe, (b)(4) units of this product family have been sold worldwide, making the rate of occurrence of this intraoperatively failure (b)(4) percent, if all complaints were confirmed. The instructions for use advises the user of the following. Do not use excessive force on instruments to avoid damage or breakage during use. Do not use instruments to pry, as bending or breakage may occur. Exercise care when using the drill bit and drill guide. Applying side or bending loads may cause drill bit breakage, oversized tunnel or generation of metal particulates. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[112885642]
The conmed representative reported on behalf of the user facility that while drilling in the medial epicondyle with y28d, the drill bit broke at the stopper. The broken device was pulled out of the bone. The procedure was completed with no reported surgical delays or patient injury. Upon gathering additional information, the patient did not require additional treatment or hospital stay due to this incident. This report is being raised on the basis of a reported malfunction with potential for injury with recurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2018-00083 |
| MDR Report Key | 7643407 |
| Date Received | 2018-06-27 |
| Date of Report | 2018-06-27 |
| Date Mfgr Received | 2018-05-31 |
| Device Manufacturer Date | 2018-04-23 |
| Date Added to Maude | 2018-06-27 |
| 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 | MRS. MARTHA CAMACHO URRIBARRI |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243051 |
| Manufacturer G1 | CONMED |
| 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 | 0 |
| Brand Name | Y-KNOT RC DISPOSABLE DRILL BIT, 2.8MM |
| Generic Name | Y-KNOT RC DISPOSABLE DRILL BIT, 2.8MM |
| Product Code | GFG |
| Date Received | 2018-06-27 |
| Catalog Number | Y28D |
| Lot Number | 920214 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED |
| Manufacturer Address | 11311 CONCEPT BLVD. LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-27 |