MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0 TI LCKNG SCR T25 SD 46 F/IM NAILS-S; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.005.436S

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

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 patient underwent revision surgery due to implants used causing the patient to lose reduction of the bone.It was unknown if the revision surgery completed successfully.It is unknown if there was a surgical delay.The patient status is unknown.This complaint involves five (5) devices.This report is for (1) 4.0 ti lckng scr t25 sd 46 f/im nails-s.This is report 5 of 5 for complaint (b)(4).

• Brand Name: 4.0 TI LCKNG SCR T25 SD 46 F/IM NAILS-S
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• 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: 12869411
• MDR Text Key: 281212091
• Report Number: 2939274-2021-06809
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982085498
• UDI-Public: (01)10886982085498
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.005.436S
• Device Catalogue Number: 04.005.436S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/24/2021
• 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: 4.0 TI LCKNG SCR T25 SD 28 F/IM NAILS-S; 4.0 TI LCKNG SCR T25 SD 30 F/IM NAILS-S; 9 TI CANNULATED HUMERAL NAIL-EX/300-SILE; TI SPIRAL BLD 42-S FOR TI HUMERAL NAILS
• Patient Outcome(s): Required Intervention