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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR GLENOID REAMER; KWT, HSD
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LIMACORPORATE S.P.A. SMR GLENOID REAMER; KWT, HSD Back to Search Results
Model Number 9075.10.300
Device Problem Dull, Blunt (2407)
Patient Problem No Code Available (3191)
Event Date 01/15/2015
Event Type  malfunction  
Event Description
During a surgery, the cutting edge of two glenoid reamers has been found to be blunt, resulting in the need by the surgeon to modify the k-wire guide to have ready a sharp reamer and perform the reaming of the glenoid successfully.This caused an extension of the surgical time by approximately 45 minutes.The event occurred in (b)(6).
 
Manufacturer Narrative
The preliminary check of the manufacturing charts of the two lot # involved (201408629 and 201408632) did not show any pre-existing anomaly on the (b)(4) pieces (15 for each lot # of reamer) released on the market.We received no other complaints on these lot #.The two instruments are being returned to us; we will analyze them and then evaluate if any corrective action is needed.Device not returned yet.
 
Manufacturer Narrative
The check of the manufacturing charts of the two lot numbers involved (201408629 and 201408632) did not show any pre-existing anomaly on the (b)(4) pieces ((b)(4) for each lot # of reamer) released on the market.We received no other complaints on these lot numbers.We also received the instruments; we verified that their cutting edge is blunt, and this has affected the functionality of the reamers when drilling the glenoid bone during surgery.These two lot numbers were manufactured in august 2014, so they are quite recent, even if we don't know how many times they were used during surgeries.The cutting edges of the returned reamers were re-sharpened internally and then placed again on the market.This is the 1st and only complaint received on these instruments.A total of (b)(4) glenoid reamers have been manufactured with the model # 9075.10.300-310-320.Although the occurrence rate is very low according to our pms data, limacorporate performed a check of all the glenoid reamers in our warehouse, with re-sharpening of the cutting edges in case that they are blunt.Moreover, all the glenoid reamers which come back for routine maintenance from the market are always checked, and their edges re-sharpened in case that they are blunt.Limacorporate is also performing internal tests to define a new design for the cutting edge of these glenoid reamers (model # 9075.10.3xx) in order to improve the functionality of the cutting edges.
 
Event Description
During a surgery, the cutting edge of two glenoid reamers has been found to be blunt, resulting in the need by the surgeon to modify the k-wire guide to have ready a sharp reamer and perform the reaming of the glenoid successfully.This caused an extension of the surgical time by approximately 45 minutes.The event occurred in (b)(6).
 
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Brand Name
SMR GLENOID REAMER
Type of Device
KWT, HSD
Manufacturer (Section D)
LIMACORPORATE S.P.A.
via nazionale 52
san daniele del friuli, udine 3303 8
IT  33038
Manufacturer (Section G)
LIMACORPORATE S.P.A.
IT  
Manufacturer Contact
giulio puppa
via nazionale 52
san daniele del friuli, udine 33038
IT   33038
MDR Report Key4514260
MDR Text Key20075310
Report Number3008021110-2015-00002
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K100858
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Remedial Action Repair
Type of Report Initial,Followup
Report Date 01/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9075.10.300
Device Lot Number1408629
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received01/16/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/06/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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