ARCOS 3.5MM HEX DRIVE
Received Jul 23, 2021 · Event occurred Jun 28, 2021
Report 0001825034-2021-02135 · MDR key 12216635
Device
Generic name
Instrument, Hip
Manufacturer
Zimmer Biomet, Inc.Model number
NICatalog number
31-301852
Lot number
ZB160507
Product problems
- Fracture
- Fracture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED A FOLLOW-UP MDR WILL BE SUBMITTED REPORT SOURCE: (B)(6).
Description of Event or Problem
IT WAS REPORTED THAT DURING INSPECTION AT THE WAREHOUSE, THE TIP OF THE INSTRUMENT WAS FOUND TO BE FRACTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION TO THE REPORTED EVEN IS UNAVAILABLE AT THIS TIME.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED DEVIATIONS OR ANOMALIES DURING MANUFACTURING, HOWEVER, THE DEVIATIONS OR ANOMALIES WOULD NOT HAVE ATTRIBUTED TO THE EVENT. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D9; G3; H2; H3. AN ARCOS 3.5MM HEX DRIVE, PART # 31-301852 FROM LOT ZB160507, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND THE TIP TO BE FRACTURED. WEAR RINGS ARE PRESENT AROUND THE SHAFT. DISCOLORATION AND SCUFFING WAS OBSERVED ON THE GRIP AND CONNECTOR. THE FEATURES OF THE FRACTURE SURFACE VISUALLY ALIGN WITH IN WHICH A TORSIONAL OVERLOAD FRACTURE FAILURE MODE WAS IDENTIFIED. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.