ZIMMER AIR DERMATOME II HOSE: UK MA-7 SCHRADER, 3 M
Received Jun 12, 2026 · Event occurred Sep 24, 2025
Report 0001526350-2026-00658 · MDR key 25485573
Device
Product problems
- Insufficient Flow or Under Infusion
- Material Split, Cut or Torn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING SURGERY THE HOSE WAS FOUND TO BE DAMAGED WITH A VISIBLE CUT. THERE WAS NO AIR LEAKAGE BUT THE AIR SUPPLY WAS INSUFFICIENT AND THE DEVICE STOPPED FUNCTIONING. DURING INVESTIGATION IT WAS FOUND THAT DEVICE WAS LEAKING AIR. THERE WAS NO PATIENT IMPACT OR DELAY. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Additional Manufacturer Narrative
THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). D10- DERMATOME AN HANDPIECE CATALOG #88710100, LOT#UNK, SERIAL# (B)(6). G2: EVENT OCCURRED IN UNITED ARAB EMIRATES. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THAT THERE WAS DAMAGE TO THE HOSE. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. ABLE TO CONFIRM REPORTED EVENT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.