MAUDE Adverse Event Report: SYNTHES RARON 3.5MM TI LCP® RECONSTRUCTION PLATE 8 HOLES/112MM; APPLIANCE,FIXATION,NAIL

Model Number	445.081
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.No patient involvement reported.Implant and explant dates: device malfunctioned with no patient involvement, was not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.Initial reporter's phone number: (b)(6).Device history records review was conducted.The report indicates that the: part: 445.081 lot: l182826, manufacturing location: (b)(4), manufacturing date: 10.Nov.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
Device report from synthes on an event in (b)(6) as follows: bfarm case:(b)(4) it was reported that an unusual breakage of a locking compression (lcp) reconstruction plate occurred.No i patient involvement.No further information was reported.This complaint involves 1 part.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Patient weight is not available for reporting.Patient identifier, age, and gender previously reported although description stated no patient involvement.Event did involve a patient.It is not known if device was implanted/explanted.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
Device report from synthes europe reports an event in (b)(4) as follows: it was reported that an unusual breakage of a locking compression (lcp) reconstruction plate occurred.No information about patient status.No further information was reported.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
An investigation summary was performed.The investigation of the complaint articles has shown that: the examination of the raw-material testing certificate and the manufacturing papers showed no deviations regarding, dimensions, material analysis, strength and structural stability.The values were in compliance with ao/asif specification and with the international standard.Conclusion: no product fault could be detected.The lcp reconstruction plate was manufactured with a lot size of (b)(4) pieces in november 2016 and we are not aware of any other complaint for this article - and lot number.If additional information is made available or the broken plate were returned, the investigation will be updated as applicable.Based on the complaint description, without product, the root cause could not be defined and no investigation or disposition is possible due to the missing material.Device 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.
Additional Manufacturer Narrative
Additional narrative: additional information, date of implant/explant.Corrected data: udi.510k.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
The original surgery took place on (b)(6) 2017.The patient was treated with a new plate in revision surgery, which took place on (b)(6) 2017.

• Brand Name: 3.5MM TI LCP® RECONSTRUCTION PLATE 8 HOLES/112MM
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES RARON; kanalstrasse west 30; raron CH394 2; SZ CH3942
• MDR Report Key: 6648837
• Report Number: 3006126083-2017-10025
• Device Sequence Number: 13694723
• Product Code: KTT
• UDI-Device Identifier: 10886982223401
• UDI-Public: (01)10886982223401(10)L182826
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K000684
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 445.081
• Device Catalogue Number: 445.081
• Device Lot Number: L182826
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: Not provided; 08/23/2017; 09/28/2017
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 06/29/2017; 08/24/2017; 10/05/2017
• Patient Sequence Number: 1
• Patient Age: 65 YR