MAUDE Adverse Event Report: SYNTHES MONUMENT 1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES

Catalog Number	03.114.001
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used in a veterinary case - no patient information will be reported.Device is an instrument and is not implanted/explanted.(b)(6).Part 03.114.001, synthes lot h161606: release to warehouse date: august 12, 2016 and december 30, 2016.Supplier: (b)(4).No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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)(6) as follows: it was found the drill guide could not be inserted into the plate hole.A second drill guide was tried and also could not be inserted into the plate hole either.The surgery was extended for twenty (20) minutes.There is no information available about patient outcome.This report is for a veterinary case; there is no human patient involvement.Concomitant device: plate (quantity 1).This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.This complaint is confirmed.This issue has been identified and escalated from a previous complaint.Appropriate actions have been initiated/taken to address the matter.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6593903
• Report Number: 1719045-2017-10505
• Device Sequence Number: 10940919
• Product Code: FZX
• UDI-Device Identifier: 10886982072986
• UDI-Public: (01)10886982072986(10)H161606
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2017

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 Catalogue Number: 03.114.001
• Device Lot Number: H161606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 06/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1