InjuryHTW
SMR Shoulder system
Received Jul 29, 2026 · Event occurred Jul 9, 2026
Report 3008021110-2026-00298 · MDR key 50069637
Device
Generic name
Long Helix Drill Dia 3.5 Mm, L. 79 Mm
Manufacturer
Limacorporate S.p.a.Model number
9084.20.086Lot number
21AR0CV
Product problems
- Break
Patient
Not reported
- Insufficient Information
Narrative
Description of Event or Problem
Intra-operative breakage of the LONG HELIX DRILL D.3,5MM, product code 9084.20.086, lot 21AR0CV occurred on (b)(6) 2026, during shoulder surgery. The metal back glenoid had to be removed and the broken part was recovered. This event occurred in Austria.
Additional Manufacturer Narrative
No pre-existing anomaly was detected by the check of the production records of lot n. 21AR0CV. This is the first and only complaint recorded on this lot number. A final report will be submitted following completion of investigation.