MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/12H/LEFT/213MM; PLATE,FIXATION,BONE

Model Number 02.112.527

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

Patient Problems Non-union Bone Fracture (2369); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Product complaint #(b)(4).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 history lot: part # 02.112.527, synthes lot # 7791417, supplier lot # 7791417, release to warehouse date: sep 11, 2014, manufactured by synthes (b)(4).No ncr's were generated during production.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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 medial distal tibia plate due to nonunion and skin breakdown.It is unknown if there was a surgical delay.Procedure outcome is unknown.This complaint involves fourteen (14) devices.This report is for (1) 3.5mm lcp low bend medial dstl tibia plate/12h/left/213mm.This report is 1 of 14 for (b)(4).

• Brand Name: 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/12H/LEFT/213MM
• 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): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12303554
• MDR Text Key: 265899535
• Report Number: 2939274-2021-04566
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982034656
• UDI-Public: (01)10886982034656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013248
• 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: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.112.527
• Device Catalogue Number: 02.112.527
• Device Lot Number: 7791417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: 4.0 MM CANCELLOUS; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention