MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR - GLENOID REAMER S-R/S; GLENOID REAMER SMALL

Model Number 9013.75.160

Device Problem Naturally Worn (2988)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/12/2023

Event Type  malfunction  

Event Description

During a primary shoulder surgery performed on (b)(6), 2023, the smr - glenoid reamer s-r/s (product code 9013.75.160, lot #19aq1nz) was found to be blunt.It was reported that patient's glenoid bone was reamed too much, and at the time of reduction the glenoid side dislocated.It was found that the bone fractured on the glenoid side.Bone grafting was performed, and the definitive glenoid implant was seated.The surgical time got extended by around 15 minutes.Patient is a female, 84 years old.Event happened in japan.

Manufacturer Narrative

Checking the dhrs of the involved lot #19aq1nz, no pre-existing anomaly was found on the 52 devices manufactured with that lot #.This is the first and only complaint received on that lot #.A final mdr is going to be submitted when the investigation is complete.

• Brand Name: SMR - GLENOID REAMER S-R/S
• Type of Device: GLENOID REAMER SMALL
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 18493462
• MDR Text Key: 333202260
• Report Number: 3008021110-2024-00003
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9013.75.160
• Device Lot Number: 19AQ1NZ
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other