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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 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.
 
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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 Key10913537
MDR Text Key219200438
Report Number3008021110-2020-00102
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 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number9013.75.355
Device Catalogue Number9013.75.355
Device Lot Number20BH04Z
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/27/2020
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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