MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7 CORTEX SCREW SLF-TPNG T8 SD REC 14; PLATE,FIXATION,BONE

Model Number 202.874

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Muscle/Tendon Damage (4532)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Patent identifier: (b)(6).Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 surgeon was removing 2.4mm va-lcp two-column volar distal radius plate because the patient had tendon irritation.Everything was removed successfully.There is no surgical delay.Procedure outcome is unknown.No patient consequence.This complaint involves ten (10) devices.This report is for (1) 2.7 cortex screw slf-tpng t8 sd rec 14.This report is 2 of 10 (b)(4).

• Brand Name: 2.7 CORTEX SCREW SLF-TPNG T8 SD REC 14
• 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: 11842151
• MDR Text Key: 251210245
• Report Number: 2939274-2021-02401
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982145062
• UDI-Public: (01)10886982145062
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 202.874
• Device Catalogue Number: 202.874
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 2.4 VA 2-CLMN VLR DRP 7H HD/2H SFT/LFT; 2.4MM VA LOCKING SCREW SDDRIVE 14MM; 2.4MM VA LOCKING SCREW SDDRIVE 18MM; 2.4MM VA LOCKING SCREW SDDRIVE 18MM; 2.4MM VA LOCKING SCREW SDDRIVE 18MM; 2.4MM VA LOCKING SCREW SDDRIVE 20MM; 2.4MM VA LOCKING SCREW SDDRIVE 20MM; 2.4MM VA LOCKING SCREW SDDRIVE 20MM; 2.4MM VA LOCKING SCREW SDDRIVE 20MM
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR