MAUDE Adverse Event Report: SYNTHES RARON 3.5MM LCP® ANTEROLATERAL DISTAL TIBIA PL 19 HOLES/RIGHT; APPLIANCE, FIXATION, NAIL

Model Number	241.454
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(therapy date): unknown date in (b)(6) 2016.Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing date: april 20, 2009.Manufacturing location: (b)(4).Business group: trauma.Device part 241.454, lot 3139420 is a batch number controlled product; therefore no service history record review is possible.No non-conformance reports 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.The conclusion of the dhr review is that the final products manufactured in the production processes relevant to the device in the current complaint met inspection requirements, certification test values, and acceptance criteria.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 revision surgery was performed on (b)(6) 2017 due to a non-union and pain.X-ray taken at a prior date showed one (1) previously implanted plate was broken and a revision surgery was scheduled to replace the plate.Radiology imaging was taken on (b)(6) 2017 for documentation and confirmed the broken plate.The initial surgery was in (b)(6) 2016.One (1) new plate and screw(s) were implanted.The revision surgery was successful and the patient is stable.There was no surgical delay.Concomitant devices reported: screws.This is report 1 of 1 for (b)(4).

• Brand Name: 3.5MM LCP® ANTEROLATERAL DISTAL TIBIA PL 19 HOLES/RIGHT
• Common Device Name: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): SYNTHES RARON; kanalstrasse west 30; raron CH394 2; SZ CH3942
• MDR Report Key: 6803859
• Report Number: 3006126083-2017-10034
• Device Sequence Number: 1722888
• Product Code: KTT
• UDI-Device Identifier: 10886982167279
• UDI-Public: (01)10886982167279(10)3139420
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K000684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 241.454
• Device Catalogue Number: 241.454
• Device Lot Number: 3139420
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 08/18/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN QUANTITY OF UNKNOWN SCREWS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR