MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP® MEDIAL DISTAL TIBIA PLATE 6 HOLES/142MM-LEFT; PLATE, FIXATION, BONE

Model Number	239.905
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown.Date of implantation is unknown date in 2015.Complainant part is not expected to be returned for manufacturer review/investigation.Part: 239.905; lot: 1388624; manufacturing site: (b)(4); release to warehouse date: october 11, 2005.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.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.(b)(4).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 or Problem Description
It was reported that on (b)(6) 2018, the patient underwent hardware removal of the locking compression plate (lcp) medial distal plate, two 3.5 mm cortex screws and five locking screws.Original implantation was performed in 2015.Almost three years after the procedure, redness down the distal tibia and infection were observed.The fracture was noted to be healed.One of the cortex screws was broken and was left in the patient's bone.Patient status and procedure outcome are unknown.This report is for a 3.5mm lcp® medial distal tibia plate 6 holes/142mm-left.This is report 1 of 4 for (b)(4).
Event or Problem Description
It was further reported that the procedure was completed successfully, with no surgical delay.The patient outcome was reported as good.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Lot number corrected.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.

• Brand Name: 3.5MM LCP® MEDIAL DISTAL TIBIA PLATE 6 HOLES/142MM-LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7865520
• Report Number: 2939274-2018-53740
• Device Sequence Number: 2013173
• Product Code: HRS
• UDI-Device Identifier: 10886982163011
• UDI-Public: (01)10886982163011
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K013248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2018

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
• Operator of Device: Health Professional
• Device Model Number: 239.905
• Device Catalogue Number: 239.905
• Device Lot Number: 1388624
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 10/12/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 75