MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR - GUIDE FOR CONICAL REAMER

Model Number 9013.52.116

Device Problem Mechanical Jam (2983)

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

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

Checking the manufacturing charts of the involved lots #17aq0vk and #15aa077, no pre-existing anomaly was found on the instruments manufactured with the same lot #s.We submit a final mdr when the investigation is complete.

Event Description

During a primary shoulder surgery performed on (b)(6) 2023, the following instruments were reported to malfunction: · smr - guide for conical reamer (product code 9013.52.116, lot #17aq0vk) · smr - tt metal back impactor (product code 9013.75.385, lot #15aa077) in details, the guide for conical reamer had a broken taper and didn't engage with the stem to ream for the reverse body.The surgeon reamed without using a guide.The tt metal back impactor had the black handle sleeve slightly loose, making it harder to position the glenosphere.Due to the malfunctioning, the surgical time got extended of 15 minutes.It was reported that the surgeon was happy with the final seating and positioning of the implant.Event happened in australia.

• Brand Name: SMR - GUIDE FOR CONICAL REAMER
• Type of Device: GUIDE FOR CONICAL REAMER
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 18526692
• MDR Text Key: 333442719
• Report Number: 3008021110-2024-00006
• Device Sequence Number: 1
• Product Code: PHX
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9013.52.116
• Device Lot Number: 17AQ0VK
• 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