MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHAFT ANGLED GLEN REAMER; SHAFT FOR ANGLED GLENOID REAMER

Model Number 9013.75.355

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

By checking the dhr of the lot #19bh0e3, no pre-existing anomalies were detected on all the components manufactured with this lot #.We will submit a final mdr once the investigation will be completed.

Event Description

Intra-op breakage of the smr shaft angled glenoid reamer (product code 9013.75.355, lot# 19bh0e3) occurred during glenoid reaming.It was reported that the force of the reaming caused the two metal flanges to break at the junction where the reamer head connects to the shaft.According to the complaint source, the surgeon was forced to use a high-speed bur to complete the glenoid preparation, resulting in a less than ideal surface on which to implant the baseplate, and in an additional surgical time.Surgery was delayed of about 20-30 minutes.Event happened in the us.

Event Description

Intra-operative breakage of the smr shaft angled glenoid reamer (product code 9013.75.355, lot# 19bh0e3) occurred on (b)(6) 2020 during the glenoid reaming phase.It was reported that the force of the reaming caused the two metal flanges to break at the junction where the reamer head connects to the shaft.According to the complaint source, the surgeon was forced to use a high-speed bur to complete the glenoid preparation, resulting in a less than ideal surface on which to implant the baseplate, and in an additional surgical time.Surgery was delayed of about 20-30 minutes.Estimated number of uses of the instrument: less than 10.Event happened in the us.

Manufacturer Narrative

By checking the dhr of the lot #19bh0e3, no pre-existing anomalies were detected on the total number of components manufactured with this lot #.Instrument was received by limacorporate and the breakage of the instrument (initially documented by pictures from the complaint source) was confirmed with a visual analysis.According to the complaint source, the instrument was used for reaming a hard bone.The product code involved in this complaint (9013.75.355 v00, shaft for angled glenoid reamer) was used on the market in controlled release phase.After receiving a total of 8 complaints from the market, technical investigation identified all the potential critical points related to the instrument geometry: a corrective action was put in place to increase the mechanical resistance of the shaft for angled glenoid reamer leading to a new version (01) of the instrument.Moreover, an additional note ("in case of hard/sclerotic glenoid bone surface, the initial glenoid drill can be optionally used to prepare the glenoid seat for reaming") in the relevant surgical technique related to the optional pre-drill step will be added.This is a final report.Limacorporate will continue monitoring the market to promptly detect any further similar issue.

• Brand Name: SMR SHAFT ANGLED GLEN REAMER
• Type of Device: SHAFT FOR ANGLED GLENOID REAMER
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 10885198
• MDR Text Key: 240779970
• Report Number: 3008021110-2020-00092
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K191746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9013.75.355
• Device Catalogue Number: 9013.75.355
• Device Lot Number: 19BH0E3
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other