PLASMAX PLUS COUNTERBALANCE
Received May 21, 2019
Report 0001825034-2019-02253 · MDR key 8629426
Device
Generic name
Instrument, Sports Medicine
Manufacturer
Zimmer Biomet, Inc.Catalog number
800-0512
Lot number
045033
Product problems
- Delivered as Unsterile Product
- Delivered as Unsterile Product
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE DEVICE IS NOT DELIVERED STERILE; NO EXPIRATION DATE. REPORTED PACKAGING DAMAGE EVENT WAS CONFIRMED VIA VISUAL EXAMINATION. IT WAS IDENTIFIED THE PACKAGING WAS DAMAGED IN TRANSIT. DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED WITH NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES IDENTIFIED. ROOT CAUSE IS ATTRIBUTED TO TRANSIT DAMAGE. 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.
Description of Event or Problem
NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORTING.
Additional Manufacturer Narrative
(B)(4). 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 DURING THE DISTRIBUTION PROCESS PACKAGING DAMAGE WITH STERILITY BARRIER POTENTIALLY COMPROMISED WAS IDENTIFIED. NO PATIENT OR SURGICAL INVOLVEMENT. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.