MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA LOCKING SCREW SDDRIVE 22MM; PLATE, FIXATION, BONE

Model Number 02.210.122

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) 2.4mm va locking screw sddrive 22mm.This is report 1 of 2 for complaint (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.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.

• Brand Name: 2.4MM VA LOCKING SCREW SDDRIVE 22MM
• Type of Device: PLATE, 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 Key: 13506730
• MDR Text Key: 287209653
• Report Number: 2939274-2022-00411
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982052995
• UDI-Public: (01)10886982052995
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071184
• Number of Events Reported: 1
• 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 Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.210.122
• Device Catalogue Number: 02.210.122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/LFT
• Patient Age: 41 YR
• Patient Sex: Female