TC TENOTOMY SCISSDELCVD1/SERR130MM

Additional Manufacturer Narrative

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 DO250R TC TENOTOMY SCISSDELCVD1/SERR130MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE SCISSOR BROKE WHILE CUTTING SOFT TISSUE. THIS OCCURRED DURING A TOTAL SHOULDER REPLACEMENT SURGERY. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. AN X-RAY WAS TAKEN INTRAOPERATIVELY; THERE WAS A DELAY OF 10-15 MINUTES. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

Additional Manufacturer Narrative

INVESTIGATION: 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: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. 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. IF THE DEVICE IS RETURNED IN THE FUTURE, AN INVESTIGATION WILL AGAIN BE COMPLETED AT THAT TIME. BASED UPON THE INVESTIGATION RESULTS A CAPA IS NOT NECESSARY.