MAUDE Adverse Event Report: SYNTHES BETTLACH LCP PROXIMAL LATERAL TIBIA PLATE 7 HOLES/180MM-LEFT; PLATE,FIXATION,BONE

Catalog Number	222.223
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing site: (b)(4).Manufacturing date: 15.July 2006.No nonconformances were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient who initially underwent surgery on (b)(6) 2016 for a left tibia fracture, was returned to the operating room on (b)(6) 2017 for the removal of a plate and eight screws due to a pseudomonas infection at the implant site.The patient was described as ¿very sick with a lot of other health issues.¿ it was reported that the initial surgery in december was prolonged due to the status of the patient¿s health.During the procedure on (b)(6), all hardware was removed intact and without difficulty.The surgeon irrigated the site and further treatment is unknown.There was no delay reported and the surgery was completed successfully.This is report 1 of 7 for (b)(4).

• Brand Name: LCP PROXIMAL LATERAL TIBIA PLATE 7 HOLES/180MM-LEFT
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 6338870
• Report Number: 9612488-2017-10059
• Device Sequence Number: 1710002
• Product Code: HRS
• UDI-Device Identifier: 10886982156570
• UDI-Public: (01)10886982156570(10)2206345
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K052390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/24/2017

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 Catalogue Number: 222.223
• Device Lot Number: 2206345
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2017
• Initial Report FDA Received Date: 02/17/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR