MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR REVERSE LINER +6 MM; REVERSE LINERS 36MM (UHMWPE) +6MM

Model Number 1360.50.820

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

By checking the dhr of the lot #19at06n, 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, after the smr reverse liner +6 mm (product code 1360.50.820, lot# 19at06n - ster.2000293) was opened onto sterile field, it was noted that the inner sterile packaging had a hair on it.Inner package was not opened but removed from field.Instruments in contact with implant packaging were removed, antimicrobial drape was placed over back table and new instruments were introduced onto field.Surgery was delayed of 5 minutes.Event happened in the us.

• Brand Name: SMR REVERSE LINER +6 MM
• Type of Device: REVERSE LINERS 36MM (UHMWPE) +6MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 11601129
• MDR Text Key: 266411151
• Report Number: 3008021110-2021-00024
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K110598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 04/01/2021

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: 1360.50.820
• Device Lot Number: 19AT06N
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other