PERLA TL MIS

Additional Manufacturer Narrative

AFTER WE RECEIVED THE COMPLAINT, THE MANUFACTURING DOCUMENTS AND QUALITY CONTROL DOCUMENTS WERE ANALYZED. RAW MATERIALS AND PRODUCTION PROCESSES ARE CONFORM TO THE SPECIFICATIONS. NO DEVIATION DURING THE MANUFACTURING PROCESS. (B)(4) DEVICES OF THE BATCH 6-6408 HAVE BEEN MANUFACTURED IN JULY 2022 AND THERE ARE (B)(4) INSTRUMENTS ON THE MARKET. THIS IS THE SECOND COMPLAINT WE RECEIVE FOR THIS BATCH, BUT THE FIRST COMPLAINT FOR THIS KIND OF ISSUE. WE RECEIVED THE INSTRUMENT AND WE CONFIRM THAT THE TIP IS BROKEN. THIS INSTRUMENT BROKE IN SITU DURING THE PROCEDURE, AND THE FRACTURED TIP WAS NOT RETRIEVED. RADIOGRAPHIC PICTURES WERE REQUESTED TO FURTHER INVESTIGATION, HOWEVER, NO PICTURE HAVE BEEN PROVIDED TO US. THE REPORTER INDICATES THAT NO ADVERSE EFFECT FOR THE PATIENT WAS OBSERVED. DUE TO THE LIMITED INFORMATION AVAILABLE, IN PARTICULAR THE ABSENCE OF SUPPORTING PICTURES AND DETAILED PROCEDURAL DATA, THE RD TEAM IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. BASED ON THE AVAILABLE INFORMATION, NO CLEAR ROOT CAUSE WAS IDENTIFIED. THIS IS AN ISOLATED CASE WITH NO PATIENT HARM. THE CASE IS CLOSED AS IS. ADDITIONALLY, DUE TO HUMAN ERROR AND OMISSION, THIS VIGILANCE REPORT WAS NOT SUBMITTED WITHIN THE REGULATORY TIMELINES. AN INTERNAL NON-CONFORMITY HAS BEEN INITIATED TO DOCUMENT THIS DEVIATION (B)(4).

Description of Event or Problem

WE RECEIVED A COMPLAINT (B)(4) FROM SPAIN (B)(6) ON (B)(6) 2025: THE CUSTOMER COMPLAINT FORM REPORTS THAT DURING REMOVAL OF THE AEL TROCAR AND THE NEEDLE TROCAR FROM THE PEDICLE, THE TIP OF ONE INSTRUMENT BROKEN SITU DURING THE PROCEDURE. THE TIP OF THE INSTRUMENT WAS NOT RETRIEVED. THERE WAS NO IMPACT ON THE PATIENT. WE REPORT THIS CASE BECAUSE THIS INSTUMENT IS MARKETED IN THE US.