MAUDE Adverse Event Report: SYNTHES MEZZOVICO 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/3H SHAFT/RIGHT; PLATE, FIXATION, BONE

Model Number	02.111.630
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Patient information not available for reporting.Device malfunctioned intra-operatively and was not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.Device history records review was conducted.The report indicates that the: part #02.111.630, lot #l316667; manufacturing site: (b)(4); manufacturing date: 02.March 2017.No ncrs were generated during production.Review of the device history record 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 a radial styloid screw would not lock into plate during a distal radius procedure on (b)(6) 2017.A new plate was used and the issue was resolved.A surgical delay of 5 minutes was noted.The procedure was completed successfully with no patient harm.This complaint involves one device.Concomitant devices reported: radial styloid screw (part # unknown, lot # unknown, quantity # unknown).This report is 1 of 1 for (b)(4).

• Brand Name: 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/3H SHAFT/RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• MDR Report Key: 6818338
• Report Number: 1000562954-2017-10212
• Device Sequence Number: 18857175
• Product Code: HRS
• UDI-Device Identifier: 10886982031990
• UDI-Public: (01)10886982031990(10)L316667
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K083694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/03/2017

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: 02.111.630
• Device Catalogue Number: 02.111.630
• Device Lot Number: L316667
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 08/24/2017
• Patient Sequence Number: 1