ARM PROTECTOR, SURGICAL, ULNAR NERVE, 1.0 DENSITY

Additional Manufacturer Narrative

THE SAMPLE NOR PICTURE OF THE SAMPLE WERE NOT RETURNED TO DEROYAL INDUSTRIES FOR EVALUATION. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE POSITIONER SUPPLIER ROGERS FOAM CORPORATION. ROOT CAUSE: WAS UNABLE TO BE DETERMINED BY SUPPLIER ROGERS FOAM CORPORATION AS SPECIFIC DEFECTIVE SAMPLES WERE NOT OBTAINED. POTENTIAL ROOT CAUSE DETERMINED BY ROGERS FOAM CORPORATION: EMPLOYEES NOT WEARING THEIR HAIRNETS CORRECTLY AND THE MOVEMENT OF THE FANS ALONG WITH POTENTIAL PRODUCTION LINE WORK PROCESS ISSUE. THE FOLLOWING CORRECTIVE AND PREVENTIVE ACTIONS HAVE TAKEN PLACE BY ROGERS FOAM CORPORATION: COMPLETED RETRAINING WITH THEIR EMPLOYEES, ADDED FANS TO THE MAINTENANCE PLAN, AND WILL DETERMINE ANOTHER MEANS OF TRANSPORTATION OF THE MATERIAL FROM TABLE TO TABLE. DEROYAL REVIEWED FAILURE MODES AND EFFECTS ANALYSIS (FMEA) AND CORRECTIVE ACTIONS AND PREVENTATIVE ACTIONS (CAPA) AND NO ISSUES WERE FOUND. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS SURROUNDING THIS ITEM AND ISSUE. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

A COMPLAINT WAS RECEIVED ON 6/7/2023 REPORTING HAIR IN BAG. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE POSITIONER SUPPLIER (B)(4). THE SAMPLE HAS NOT BEEN RETURNED TO DEROYAL FOR EVALUATION AT THIS TIME. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

HAIR IN BAG.