2.5 MM FEMALE HEX SCREW 25 MM LENGTH
Received Dec 17, 2019 · Event occurred Dec 4, 2019
Report 0001822565-2019-05307 · MDR key 9480405
Device
Generic name
Prosthesis, Knee
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
42509902525
Lot number
64454607
Product problems
- Device Contaminated During Manufacture or Shipping
- Device Contaminated During Manufacture or Shipping
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). REPORT SOURCE - (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT WHEN THE CUSTOMER OPENED THE PACKAGE, THERE WAS FOREIGN MATTER INSIDE THE STERILE PACKAGE. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.
Additional Manufacturer Narrative
THIS REPORT IS BEING SUBMITTED TO UPDATE THE INITIAL REPORTER INFORMATION WITH THE DOCTOR'S NAME.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. EVALUATION OF THE PROVIDED PICTURES NOTED THE PRESENCE OF A CIRCULAR TRANSLUCENT SPECK ON THE FLANGE OF THE PLASTIC RETAINER OR INNER CAVITY. IT COULD NOT BE DETERMINED WHETHER THE FOREIGN SUBSTANCE RESTED ON TOP OF THE RETAINER FLANGE OR WAS STUCK BETWEEN THE RETAINER FLANGE AND INNER CAVITY. THE LID OF THE INNER CAVITY WAS COMPLETELY PEELED OFF AND THERE IS UNIFORM GLUE REMAIN ALL OVER THE INNER CAVITY SEALING FLANGE. THE FOREIGN SUBSTANCE WAS RETURNED IN A PLASTIC BAG TAPED TO THE RETAINER, WITH THE WHOLE PRODUCT AND PACKAGING. THE PRODUCTS WERE STILL PACKAGED WITHIN THE PROTECTIVE POUCH AND PLASTIC BAG INSIDE THE INNER CAVITY UNDERNEATH THE PLASTIC RETAINER. REPORTED EVENT IS FOR A PACKAGING ISSUE; MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. THE LIKELY CONDITION OF THE PRODUCTS WHEN IT LEFT ZIMMER BIOMET WAS CONFORMING TO SPECIFICATIONS BASED ON THE DHR REVIEW AND EVALUATION OF THE RETURNED PRODUCT. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.