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

Catalog Number	02.127.231
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient (b)(6).Additional product code: hwc.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device history records review was conducted.The report indicates that: dhr review for: part#02.127.231 lot#l059998, manufacturing location: (b)(4), manufacturing date: 14.Jul.2016.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 revision surgery occurred on (b)(6) 2016 due to backing out of screws and the proximal locking screws would not engage.The patient had bilateral proximal tibia and femur fractures treated on (b)(6) 2016.Patient also had a previous left unknown tibial nail implanted on an unknown date.On (b)(6) 2016 the exfixes were removed and patient had bilateral open reduction internal fixation (orif) of the proximal tibias and retrograde left femur.The patient returned to surgery on (b)(6) 2016 for irrigation and debridement of the left tibia with removal of hardware.Clinical findings included infection and inflammation and an antibiotic cement spacer was placed.The surgery was successfully completed with no delays and no harm to the patient.This complaint involves three (3) devices.Concomitant device reported: tibial nail (quantity 1), external fixators.This report is 3 of 3 for (b)(4).

• 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: 6205083
• Report Number: 3006126083-2016-10043
• Device Sequence Number: 862804
• Product Code: HRS
• UDI-Device Identifier: 10886982043566
• UDI-Public: (01)10886982043566(10)L059998
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K120689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/01/2016

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: 02.127.231
• Device Lot Number: L059998
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2016
• Initial Report FDA Received Date: 12/27/2016
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXTERNAL FIXATORS (PART & LOT UNK, QTY UNK); TIBIAL NAIL (PART & LOT UNK, QTY 1)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 75