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 Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

By checking the dhr of the lot #20bh04z, no pre-existing anomalies were detected on the 10 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) 2020, the connector shaft tip of the smr shaft angled glenoid reamer (product code (b)(4), lot# 20bh04z) broke into pieces upon reaming, thus separating the fully assembled reamer.According to the information reported by the complaint source, the instruments were properly assembled.Surgeon was able to prepare the glenoid before the reamer assembly broke, thus he stated to be comfortable implanting the baseplate.Surgery prolonged of about 5-10 minutes.Event happened in the us.

Event Description

During shoulder surgery performed on (b)(6) 2020, the connector shaft tip of the smr shaft angled glenoid reamer (product code 9013.75.355, lot# 20bh04z) broke into pieces upon reaming, thus separating the fully assembled reamer.According to the information reported by the complaint source, the instruments were properly assembled.Surgeon was able to prepare the glenoid before the reamer assembly broke, thus he stated to be comfortable implanting the baseplate.Estimated number of uses of the instrument is unknown.Surgery prolonged of about 5-10 minutes.Event happened in the us.

Manufacturer Narrative

By checking the dhr of the lot #20bh04z, no pre-existing anomalies were detected on a total of (b)(4) pieces manufactured with this lot#.We did not receive any picture of the broken pieces nor the instrument itself involved in this complaint.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: 10913537
• MDR Text Key: 219200438
• Report Number: 3008021110-2020-00102
• 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: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2020
• 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: 20BH04Z
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other