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

Model Number 02.111.531

Device Problems Mechanical Problem (1384); No Apparent Adverse Event (3189)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Additional product code: hwc.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.(b)(4).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 on (b)(6) 2021, the patient underwent removal of distal radius plate and guide bock due to malfunctioned.The distal radius plate and guide bock were removed and was replaced.The primary implantation was on (b)(6) 2021.The distal radius plate and guide block were removed with defects/malfunction and were replaced.Concomitant devices reported: unknown screws (part# unknown, lot# unknown, quantity unknown).This report is for one (1) 2.4mm va-lcp 2-col dstl rad pl nrw 6h hd/3h shaft/lt.This is report 2 of 2 for complaint (b)(4).

• Brand Name: 2.4 VA 2-COL DRP NRW 6H HD/3H SFT/LT
• 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): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12495766
• MDR Text Key: 272165760
• Report Number: 2939274-2021-05585
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982031778
• UDI-Public: (01)10886982031778
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.111.531
• Device Catalogue Number: 02.111.531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: GUIDE BLOCK TWO-COLM PL/NARROW 6H HD/LT; UNK - SCREWS: DISTAL RADIUS; GUIDE BLOCK TWO-COLM PL/NARROW 6H HD/LT; UNK - SCREWS: DISTAL RADIUS
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female