Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR - GLENOID DRILL SMALL-R; GLENOID DRILL - SMALL-R
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LIMACORPORATE S.P.A. SMR - GLENOID DRILL SMALL-R; GLENOID DRILL - SMALL-R Back to Search Results
Model Number 9013.75.225
Device Problem Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/24/2022
Event Type  malfunction  
Manufacturer Narrative
Checking the manufacturing charts of the involved lot #20bh12u, no pre-existing anomaly was found on the components manufactured with the same lot #.This is the first and only complaint received on this lot #.We will submit a final mdr as soon as the investigation is completed.
 
Event Description
During a primary shoulder surgery performed on (b)(6) 2022, the smr - glenoid drill small-r (product code 9013.75.225, lot #20bh12u) is used to ream the glenoid bone, however when impacting the glenoid small-r metalback (product code 1375.20.005, lot #2201126 - product not sold in the us), the glenoid implant sat 2mm off the glenoid bone.It was reported that the implant was removed and the glenoid reamed again with the same reamer: the same situation occurred when reimplanting the implant.After ensuring nothing was impeding the seating, the implant was placed in a third time, however it continued to sit 2mm proud according to the complaint source.The metalback was upsized to glenoid small metalback (product code 1375.20.020, lot #2105024 - product not sold in the us): the glenoid was reamed using the small reamer and the metalback seated flush into the glenoid.It was reported that surgery got prolonged by 20 minutes due to the issue.The number of uses of the instrument is not known.Event happened in (b)(6).
 
Manufacturer Narrative
Checking the manufacturing charts of the involved lot #20bh12u, no pre-existing anomaly was found on the components manufactured with the same lot #.This is the first and only complaint received on this lot #.Further checking the manufacturing charts of the involved lot #2201126, no pre-existing anomaly was found on the 70 components manufactured with the same lot #.According to our records, at least 63 out of 70 metalbacks with lot #2201126 and ster.2200072 have been implanted, and no complaint has been received on this lot #.Device analysis: the drill involved was returned to limacorporate for further analysis.Dimensional analysis was performed on the item returned and it was confirmed to be compliant to the specifications.In addition, a total of four further glenoid drills belonging to the same lot #20bh12u were retrieved for a deep and complete analysis: their dimensions were checked, and no anomaly was found.It was noted by a visual analysis that the thread of the cutting edges of the glenoid drill involved in the complaint is jagged.It was reported by the complaint source that the number of uses of the instrument is not known, however it can hypothesized that wear and tear of the device due to repeated use over time is the cause to the thread's damages.Indeed, the threads of the cutting edges of the four retrieved drills belonging to the same lot # were checked: no damages were observed (the four instruments have indeed not been used yet).By considering that: check of the manufacturing charts highlighted no anomalies on the total number of components manufactured with lot #20bh12u; the dimensional analysis on the returned drill involved in the complaint confirmed that the device was complaint to the specifications; visual analysis on the glenoid drill involved in the complaint confirmed that the thread of the cutting edges is jagged; we can hypothesize that wear and tear of the glenoid drill caused the jaggings on the cutting edges, which prevent the instrument to function as per intended use, determining a lower cutting efficiency for the device.The impact of lower cutting efficiency could be emphasized in case of sclerotic bone.Therefore, we can state that the event was not product related.Pms data: according to our pms data, this is the first complaint received on instruments belonging to product code 9013.75.225.Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.
 
Event Description
During a primary shoulder surgery performed on (b)(6) 2022, the smr - glenoid drill small-r (product code 9013.75.225, lot #20bh12u) was used to ream the glenoid bone, however when impacting the glenoid small-r metal back (product code 1375.20.005, lot #2201126 - product not sold in the us ), the glenoid implant sat 2mm off the glenoid bone.It was reported that the implant was removed and the glenoid bone reamed again with the same reamer: again, the situation occurred when reimplanting the metal back component.After ensuring nothing was impeding the seating, the implant was placed in a third time, however, according to the complaint source, it continued to sit 2mm proud.The metal back component was at the end upsized to glenoid small metalback (product code 1375.20.020, lot #2105024 - product not sold in the us): the glenoid was reamed using the small reamer and the metal back component seated flush into the glenoid.It was reported that surgery got prolonged by 20 minutes due to the issue.The number of uses of the instrument is not known.Event happened in australia.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SMR - GLENOID DRILL SMALL-R
Type of Device
GLENOID DRILL - SMALL-R
Manufacturer (Section D)
LIMACORPORATE S.P.A.
via nazionale 52
villanova di san daniele, udine 33038
IT  33038
MDR Report Key14904345
MDR Text Key295320393
Report Number3008021110-2022-00060
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
PMA/PMN Number
K100858
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/05/2022
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 Model Number9013.75.225
Device Lot Number20BH12U
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/04/2022
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/06/2022
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) Required Intervention;
-
-