MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4 VA 2-CLMN VLR DRP 6H HD/3H SFT/LFT; PLATE, FIXATION, BONE

Model Number 02.111.631

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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.

Event Description

It was reported that, the variable angle locking screw was powered through the variable angle locking compression plate (va-lcp) distal radius plate, while putting a screw in the power in the left wrist of the screw went to the plate.The screw was removed by continuing to push all the way through and removed the dorsal, on the other side of the wrist.This report is for (1) 2.4 va 2-clmn vlr drp 6h hd/3h sft/lft.This is report 1 of 2 for complaint (b)(4).

• Brand Name: 2.4 VA 2-CLMN VLR DRP 6H HD/3H SFT/LFT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12548765
• MDR Text Key: 273885582
• Report Number: 2939274-2021-05799
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982032010
• UDI-Public: (01)10886982032010
• Combination Product (y/n): N
• PMA/PMN Number: K083694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.111.631
• Device Catalogue Number: 02.111.631
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2021
• 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: 2.4MM VA LOCKING SCREW SDDRIVE 26MM