MAUDE Adverse Event Report: SYNTHES RARON 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/5H SHAFT/LEFT; PLATE,FIXATION,BONE

Model Number	02.111.751
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review was completed.Manufacturing site: (b)(4), manufacturing date: 16.May.2014.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.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 patient was implanted with a 2.4 mm variable angle locking compression plate (va-lcp) two-column volar distal radius plate 7 hole head 5 hole shaft-left and an unknown quantity of unknown screws in the left wrist on (b)(6) 2016 as the result of a motorcycle accident.Patient was also implanted with one (1) unknown bar and an unknown quantity of unknown screws in the outer part of the forearm.Patient presented with pain and discomfort on unknown date.X-rays revealed the plate was broken in half, three (3) screw heads had broken off the shafts, and patient had a non-union.The bar implanted in the forearm was intact.Patient was returned to surgery on (b)(6) 2017 where all hardware was removed.The three (3) screw heads were removed but the screw shafts remained embedded in patient bone; one (1) in the radial styloid and two (2) in the radius shaft.No additional hardware was implanted at that time.During a routine follow up visit on (b)(6) 2017, surgeon removed patient¿s stitches and scheduled another revision for (b)(6) 2017.During the (b)(6) 2017 revision, a bone graft was taken from the patient¿s hip and placed in the radius.The broken screw shaft from the radial styloid was removed and the two (2) screw shafts in the radius shaft remain embedded in patient¿s bone.Surgeon then placed a lag screw and plated it with a 7 hole head 7 hole shaft va diameta plate-left.There were no complications during this revision and no surgical delay was reported.This report is for one (1) 2.4 mm va lcp 2 column volar distal radius plate 7 hole head 5 hole shaft-left.This is report 1 of 2 for (b)(4).

• Brand Name: 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/5H SHAFT/LEFT
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES RARON; kanalstrasse west 30; raron CH394 2; SZ CH3942
• MDR Report Key: 6895146
• Report Number: 3006126083-2017-10043
• Device Sequence Number: 18859058
• Product Code: HRS
• UDI-Device Identifier: 10886982032393
• UDI-Public: (01)10886982032393(10)8969848
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K083694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.111.751
• Device Catalogue Number: 02.111.751
• Device Lot Number: 8969848
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 09/26/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 98