MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: LCP LOW BEND MEDIAL DISTAL TIBIA PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problem Non-union Bone Fracture (2369)

Event Date 05/04/2022

Event Type  Injury  

Manufacturer Narrative

Additional narrative: brand name, common device name, procode, manufacturer name, lot #, pma/510k: this report is for an unknown - constructs: lcp low bend medial distal tibia plate/screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr: the investigation could not be completed; no conclusion could be drawn, as no product was received.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) 2022, surgeon, grafted bone non union of a distal tibia.The patient had existing synthes hardware which included a medial distal tibia plate and screws.No direct complaints were made against the hardware.There was no patient consequence.This report is for one (1) unknown constructs: lcp low bend medial distal tibia plate/screws.This is report 1 of 1 for complaint (b)(4).

• Brand Name: UNK - CONSTRUCTS: LCP LOW BEND MEDIAL DISTAL TIBIA PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380
• MDR Report Key: 14565059
• MDR Text Key: 293081802
• Report Number: 2939274-2022-01964
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR