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

Model Number 9013.75.355

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2021

Event Type  malfunction  

Manufacturer Narrative

By checking the dhr of the lot #20bh04z, no pre-existing anomalies were detected on the pieces manufactured with this lot #.We will submit a final mdr once the investigation will be completed.

Event Description

During shoulder surgery performed on (b)(6) 2021, upon reaming, the smr shaft angled glenoid reamer (product code 9013.75.355, lot# 20bh04z) broke.According to the information reported, the instrument was used no more than 5 times.Surgery was delayed of 5 minutes.Event happened in the us.

• Brand Name: SMR SHAFT ANGLED GLEN REAMER
• Type of Device: 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: 11594989
• MDR Text Key: 244382320
• Report Number: 3008021110-2021-00021
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K191746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 03/31/2021

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 Operator: No Information
• Device Model Number: 9013.75.355
• Device Catalogue Number: 9013.75.355
• Device Lot Number: 20BH04Z
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/31/2021
• 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