MAUDE Adverse Event Report: LIMACORPORATE SPA SMR - STEM IMPACTOR; QUICK CONNECTION STEM IMPACTOR

Model Number 9013.02.302

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

By checking the dhrs of the lot #16aa017, no pre-existing anomalies were detected on the instruments 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

Intra-operative issue occurred during shoulder surgery performed on (b)(6) 2020: breakage of the stem impactor (code 901302302, lot 16aa017) in the attempt to remove the broach from the humerus.Event happened in the us.

• Brand Name: SMR - STEM IMPACTOR
• Type of Device: QUICK CONNECTION STEM IMPACTOR
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 11054686
• MDR Text Key: 223614454
• Report Number: 3008021110-2020-00115
• 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
• Report Date: 12/22/2020

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: Health Professional
• Device Model Number: 9013.02.302
• Device Lot Number: 16AA017
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 12/22/2020
• 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): Hospitalization