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

Model Number	02.111.631
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided for reporting.Incident occurred intraoperative.Device was not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Device history records review was completed for part# 02.111.631, lot# l508220.Manufacturing location: (b)(4), manufacturing date: jul 27, 2017.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 during repair of the distal radius on (b)(6) 2017, the surgeon went to affix the distal radius plate with the first screw in one of the locking holes and the screw would not lock in or seat to the plate as expected.The plate and screw were removed from the patient and a backup plate and screw available (possibly the same part numbers) in the set were implanted in the patient without issue.There was a five-minute delay as the backup devices were retrieved from the readily available set.Procedure was completed successfully with patient in stable condition.Upon inspection of the devices, the reporter stated that one of the holes in the plate looks as though it was not machined properly.He further explained that one of the four holes on the variable angle plate has threads that are malformed or "messed up".Concomitant devices reported: screwdriver (part # unknown, lot # unknown, quantity 1).This report is for one (1) 2.4 mm distal radius plate.This is report 1 of 2 for (b)(4).

• Brand Name: 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/3H SHAFT/LEFT
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• MDR Report Key: 7013938
• Report Number: 1000562954-2017-10244
• Device Sequence Number: 1745020
• Product Code: HRS
• UDI-Device Identifier: 10886982032010
• UDI-Public: (01)10886982032010(10)L508220
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/14/2017

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: Physician
• Device Model Number: 02.111.631
• Device Catalogue Number: 02.111.631
• Device Lot Number: L508220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2017
• Initial Report FDA Received Date: 11/09/2017
• Patient Sequence Number: 1