UNKNOWN
Received Sep 21, 2016 · Event occurred Jul 8, 2016
Report 3004774118-2016-00077 · MDR key 5965890
Device
Product problems
- Break
- Break
Patient
55 YR
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
ON 08/22/2016 K2M, INC. RECEIVED A COPY OF THE USER REPORT (B)(4) FROM (B)(6). K2M, INC. HAS BEEN UNABLE TO DETERMINE THE PRODUCT TO WHICH THIS REPORT PERTAINS, AS THE REPORT DID NOT PROVIDE A PART OR LOT NUMBER AND THE PRODUCT HAS NOT BEEN RETURNED. WE HAVE MADE SEVERAL ATTEMPTS TO CONTACT THE INITIAL REPORTER IN AN EFFORT TO OBTAIN FURTHER IDENTIFYING INFORMATION REGARDING THE PRODUCT, TO NO AVAIL. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED, K2M INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS.
Description of Event or Problem
ON 08/22/2016 K2M, INC. RECEIVED A COPY OF THE USER SUBMITTED REPORT WHICH STATED: EVENT DESC: DOUBLE BLADED KNIFE HANDLE USED TO DISSECT THROUGH SOFT TISSUE AND BONE. SMALL PORTION OF TIP BROKE OFF AND WAS NON-RETRIEVABLE. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.