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

Model Number 02.111.631

Device Problem Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided for reporting.Device was not explanted.Explant date is not applicable.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 Description

It was reported that on (b)(6) 2018, patient underwent an open reduction internal fixation (orif) surgery.The patient was being implanted with a variable angle (va) locking compression plate (lcp) two-column volar distal radius plate.During the surgery, it was noted that the locking screw failed to lock in most distal locking hole on the shaft of the plate.The failed screw was discarded.The plate was fixed using other nine (9) 2.4 variable angle locking screws.The surgery was completed successfully with no delay.The patient outcome was not reported.This report is for one (1) 2.4mm va-lcp 2-clmn vlr dstl radius pl 6h hd/3h shaft/left.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

The initial complaint was reviewed and found not reportable.The information in this complaint record reasonably suggests that there is no allegation of a complaint against this device and there is no reported malfunction or adverse event caused or contributed to with this device.The device functioned as intended.Should further information become available this determination will be reviewed.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.

• Brand Name: 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/3H SHAFT/LEFT
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7491744
• MDR Text Key: 107570648
• Report Number: 2939274-2018-52056
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982032010
• UDI-Public: (01)10886982032010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.111.631
• Device Catalogue Number: 02.111.631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1