MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; SHAFT FOR ANGLED GLENOID REAMER

Model Number	9013.75.355
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: a review of the device history records (dhrs) for lot no.21bh06q was conducted.No pre-existing anomalies were identified among the devices manufactured within the same lot.A final mdr report will be shared upon completion of the investigation.
Event or Problem Description
During a shoulder surgery performed on (b)(6) 2026, while reaming for a 19-degree augment, the smr shaft angled glen reamer (product code 9013.75.355, lot no.21bh06q) engaged with a retractor, resulting in fracture of the distal tip of the reamer shaft.The detached part fell into patient and then removed.As this was a regional case, a drop set was available on site.The instrument was replaced, and the procedure was completed without further complications.The surgery was delayed by less than 15 minutes.The patient is a 63-year-old male.Event happened in australia.

• Brand Name: SMR SHOULDER
• Common Device Name: SHAFT FOR ANGLED GLENOID REAMER
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 24377891
• Report Number: 3008021110-2026-00133
• Device Sequence Number: 4941616
• Product Code: PHX
• UDI-Device Identifier: 08033390167277
• UDI-Public: 08033390167277
• Combination Product (Y/N): N
• PMA/510(K) Number: K191746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 9013.75.355
• Device Catalogue Number: 9013.75.355
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 05/18/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown