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

Model Number 9013.02.302

Device Problem Break (1069)

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

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

We will submit the final mdr as soon as the investigation will be completed.

Event Description

Intra-operative issue occurred during shoulder surgery on (b)(6) 2020: breakage of the broach handle with code (b)(4) and lot# 14aa250.According to the information received, the surgery was positively completed, but 60 additional minutes were needed due to this issue.Event occurred in usa.

• 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: 11046519
• MDR Text Key: 241254853
• Report Number: 3008021110-2020-00118
• 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: 12/21/2020
• 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: 14AA250
• Date Manufacturer Received: 12/16/2020
• 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