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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHAFT ANGLED GLEN REAMER; SHAFT FOR ANGLED GLENOID REAMER
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LIMACORPORATE S.P.A. SMR SHAFT ANGLED GLEN REAMER; SHAFT FOR ANGLED GLENOID REAMER Back to Search Results
Model Number 9013.75.355
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 09/02/2020
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 #.This is the first and only complaint received on this lot number.We will submit a final mdr once the investigation will be completed.
 
Event Description
Breakage of instrument occurred during a shoulder surgery on (b)(6) 2020.The connector shaft tip of the instrument smr shaft angled glen reamer (product code 9013.75.355, lot# 19bh0e3) broke into pieces upon reaming the face of glenoid.Fallen pieces were appropriately removed using a curved tonsil.Surgery was concluded using a guide to confirm the correct reamed bone depth.An elevator was used to remove any remaining bone needed to properly seat the implant.Since the surgeon concluded surgery using instruments other than the ones planned per surgical technique, the implant was not seated to the full extent of his preference.Surgery was delayed of about 15 minutes.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.By a visual analysis, the breakage of the instrument was confirmed.The surgeon involved in the intra-operative event spontaneously reported that the breakage occurred was not attributable to the instrument itself as it was realized only after the surgery that the instrumentalist had assembled the related components in an inappropriate way, overloading the system.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.
 
Event Description
Breakage of instrument occurred during a shoulder surgery on (b)(6) 2020.The connector shaft tip of the instrument smr shaft angled glen reamer (product code 9013.75.355, lot# 19bh0e3) broke into pieces upon reaming the face of glenoid.Fallen pieces were appropriately removed using a curved tonsil.Surgery was concluded using a guide to confirm the correct reamed bone depth.An elevator was used to remove any remaining bone needed to properly seat the implant.Since the surgeon concluded surgery using instruments other than the ones planned per surgical technique, the implant was not seated to the full extent of his preference.Surgery was delayed of about 15 minutes.Estimated number of uses of the instrument ~1-10 times.Event happened in the us.
 
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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 Key10521153
MDR Text Key223184939
Report Number3008021110-2020-00066
Device Sequence Number1
Product Code MBF
Combination Product (y/n)N
PMA/PMN Number
K191746
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 02/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number9013.75.355
Device Catalogue Number9013.75.355
Device Lot Number19BH0E3
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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