MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: TIBIA; PLATE, FIXATION, BONE

Catalog Number UNK - PLATES: TIBIA

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

Patient Problem Electric Shock (2554)

Event Date 03/11/2021

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for an unknown device/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.The lot number was unknown.Therefore, the expiration date and device manufacture date were unknown.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.

Event Description

This is report 2 of 2 for (b)(4).It was reported that on (b)(6) 2021, a caller stated that she was implanted with a synthes tibia titanium plate and synthes titanium nail in 2017.It was reported that sometimes in 2021, she started experiencing electrical current going through her body from the implant site.It was reported that lately the symptoms persisted and were becoming unbearable.Caller visited her doctor but they could not find anything.The status of the patient was unknown.No additional information was provided.This report is for one (1) unk - plates: tibia device.This complaint involves two(2) devices.

• Brand Name: UNK - PLATES: TIBIA
• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14250990
• MDR Text Key: 290387925
• Report Number: 2939274-2022-01544
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - PLATES: TIBIA
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention