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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

By the check of the dhrs, no pre-existing anomaly was found on the (b)(4) instruments placed on the market with the same lot# 20bh01d.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: the tip of the smr shaft angled glenoid reamer code 9013.75.355 lot 20bh01d broke while reaming the bone.According to the information received, the surgery was completed using another instrument and the surgery time was prolonged of 10 minutes.No other consequences reported for the patient.It was reported that the surgeon remarked patient bone was tough.Event occurred in the usa.

Manufacturer Narrative

By the check of the dhrs, no pre-existing anomaly was found on a total of 10 instruments placed on the market with the same lot number (20bh01d).We did not have the chance to receive a picture of the broken tip nor to receive back the relevant instrument.It is important to underline that the surgeon gave evidence of the use of the reamer on a patient tough 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.Limacorporate will continue monitoring the market to promptly detect any further similar issue.This is a final mdr.

Event Description

Intra-operative issue occurred during a shoulder surgery on (b)(6) 2020: the tip of the smr shaft angled glenoid reamer - product code 9013.75.355 lot 20bh01d - broke while reaming patient bone.According to the information received, the surgery was completed using another instrument available in the tray and the surgery time was prolonged of 10 minutes.No other consequences reported for the patient.It was reported that the surgeon remarked patient bone was tough.Event occurred in the usa.

• 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: 11046501
• MDR Text Key: 223183116
• Report Number: 3008021110-2020-00117
• 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: 02/23/2021

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: 9013.75.355
• Device Catalogue Number: 9013.75.355
• Device Lot Number: 20BH01D
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization