MAUDE Adverse Event Report: SYNTHES RARON 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/8H/147MM/LEFT; PLATE, FIXATION, BONE

Model Number	02.127.231
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Infection (1933)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient height is (b)(6) cm and (b)(6) bmi.Event date is unknown since we do not know when the infection occurred.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record review was performed for the subject device lot number 9026387.Manufacturing location: (b)(4).Date of manufacture: 27.Jun.2014.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 patient had original surgery on (b)(6) 2017 for treatment of a left proximal tibia fracture.Patient was originally implanted with one (1) 3.5 mm variable angle (va) locking compression plate (lcp) proximal tibia plate and ten (10) variable angle locking screws.Post-operative, on an unknown date, patient presented with an infection.On (b)(6) 2017, surgeon removed all implants and revised the patient to a competitor¿s device.It was reported that no fragments were generated during implant removal.Surgeon performed a debridement procedure at the wound site.It was also reported that the surgeon found a tip of a pencil imbedded in the skin at the wound site.Revision surgery was completed successfully with no time delay.Patient is reported in stable condition.This is report 1 of 11 for com-(b)(4).
Additional Manufacturer Narrative
Additional classification code: hwc.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 VA-LCP PROX TIBIA PLATE SMALL BEND/8H/147MM/LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES RARON; kanalstrasse west 30; raron CH394 2; SZ CH3942
• MDR Report Key: 6623249
• Report Number: 3006126083-2017-10022
• Device Sequence Number: 613916
• Product Code: HRS
• UDI-Device Identifier: 10886982043566
• UDI-Public: (01)10886982043566(10)9026387
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2017

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 Model Number: 02.127.231
• Device Catalogue Number: 02.127.231
• Device Lot Number: 9026387
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 07/10/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 50