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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSE GLENOID BASPLT INSRTR SCREWDRVR T20; SCREWDRIVER
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TORNIER INC TORNIER PERFORM REVERSE GLENOID BASPLT INSRTR SCREWDRVR T20; SCREWDRIVER Back to Search Results
Catalog Number MWJ123
Device Problems Break (1069); Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/05/2024
Event Type  malfunction  
Event Description
During a revision case, the screwdriver tip broke off intraoperatively during the initial attempt to disengage and unscrew the glenosphere, likely due to excessive torque.A replacement screwdriver was used, and the procedure continued without further issues.Debris from the broken tip was successfully removed from the surgical field.The broken screwdriver had been heavily used for approximately 5+ years as part of a consigned kit.
 
Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
 
Event Description
During a revision case, the screwdriver tip broke off intraoperatively during the initial attempt to disengage and unscrew the glenosphere, likely due to excessive torque.A replacement screwdriver was used, and the procedure continued without further issues.Debris from the broken tip was successfully removed from the surgical field.The broken screwdriver had been heavily used for approximately 5+ years as part of a consigned kit.
 
Manufacturer Narrative
Corrections: d4 lot #, h6 component code.The reported event was confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the visual inspection was performed on returned device and revealed the device is heavily used and driver tip is broken; circular grooves and scratches around the diameter of the driver shaft can be seen.The broken part is not returned for inspection.Also, few watermarks can be seen over the periphery of the driver shaft mainly due to the reprocessing cycle.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a user related issue.The failure was caused due to the application of excessive torsional forces to the screwdriver bit which resulted in breakage of the driver end.Additionally, heavy usage of the device over the time involving multiple cleaning and sterilization cycles for surgery purpose causing circular grooves and scratches over the screwdriver shaft.If any further information is provided, the complaint report will be updated.
 
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Brand Name
TORNIER PERFORM REVERSE GLENOID BASPLT INSRTR SCREWDRVR T20
Type of Device
SCREWDRIVER
Manufacturer (Section D)
TORNIER INC
10801 nesbitt avenue s
bloomington MN 55437
Manufacturer (Section G)
TORNIER INC
10801 nesbitt avenue s
bloomington MN 55437
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key19015099
MDR Text Key339094609
Report Number0001649390-2024-00154
Device Sequence Number1
Product Code HXX
UDI-Device Identifier00846832062461
UDI-Public00846832062461
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/22/2024
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 Lay User/Patient
Device Catalogue NumberMWJ123
Device Lot NumberAZ2619241
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/05/2024
Initial Date FDA Received04/01/2024
Supplement Dates Manufacturer Received04/25/2024
Supplement Dates FDA Received05/22/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2020
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 SexMale
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