GIGLI WIRE SAW IN 6 PARTS 300MM LONG
Received Nov 16, 2021 · Event occurred Oct 12, 2021
Report 9610612-2021-00713 · MDR key 12820515
Device
Product problems
- Break
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS WERE NOT ABLE TO BE CHECKED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FH413 - GIGLI WIRE SAW IN 6 PARTS 300MM LONG. ACCORDING TO THE COMPLAINT DESCRIPTION, A JIGSAW WAS USED TO REMOVE THE ACETABULUM DURING SALTER SURGERY. AFTER SURGERY, MRI IMAGING WAS PERFORMED, AND IT WAS CONFIRMED THAT HALATION (ARTIFACT) APPEARED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER (B)(4).