MAUDE Adverse Event Report: Limacorporate S.p.A. SMR Shoulder system; Long Helix Drill Dia 3.5 mm, L. 79 mm

Model Number	9084.20.086
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: SMR Shoulder system
• Common Device Name: Long Helix Drill Dia 3.5 mm, L. 79 mm
• Manufacturer (Section D): Limacorporate S.p.A.; via nazionale, 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 50069637
• Report Number: 3008021110-2026-00298
• Device Sequence Number: 10288040
• Product Code: HTW
• UDI-Device Identifier: 08033390099684
• UDI-Public: 08033390099684
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9084.20.086
• Device Lot Number: 21AR0CV
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown