MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR - EXPANSION EXTRACTOR

Model Number 9013.52.165

Device Problem Fitting Problem (2183)

Patient Problem Insufficient Information (4580)

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

By checking the dhr of the lot #18aq1g4, no pre-existing anomalies were detected on the pieces manufactured with this lot #.This is the first and only complaint received on this lot#.We will submit a final mdr once the investigation will be completed.

Event Description

During shoulder surgery performed on (b)(6) 2021, the stem from the proximal humeral body was going to be extracted but the smr - expansion extractor (product code 9013.52.165, lot# 18aq1g4) would not fit far enough on to extract off.Surgery was prolonged of 20 minutes.Event happened in the us.

• Brand Name: SMR - EXPANSION EXTRACTOR
• Type of Device: EXPANSION EXTRACTOR
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 11789067
• MDR Text Key: 252168733
• Report Number: 3008021110-2021-00035
• 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
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9013.52.165
• Device Lot Number: 18AQ1G4
• 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