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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/LFT PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/LFT PLATE, FIXATION, BONE Back to Search Results
Model Number 02.111.731
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2022
Event Type  malfunction  
Event Description
It was reported that on (b)(6), 2022, the variable angle locking screw had trouble locking into variable angle locking compression plate (va-lcp) volar distal radius plate. The screw hole was left empty. Procedure was completed successfully without any surgical delay. Concomitant device reported: unknown screwdriver (part# unknown, lot# unknown, quantity 1). This report is for one (1) 2. 4 va 2-clmn vlr drp 7h hd/3h sft/lft. This is report 1 of 2 for complaint pc-(b)(4).
 
Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/LFT
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13506729
MDR Text Key289754698
Report Number2939274-2022-00410
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083694
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number02.111.731
Device Catalogue Number02.111.731
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/10/2022 Patient Sequence Number: 1
Treatment
2.4MM VA LOCKING SCREW SDDRIVE 22MM
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