MAUDE Adverse Event Report: SYNTHES USA 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT

Catalog Number 241.903S

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).At this time, it is unknown if/when the revision procedure took place.The complainant parts are expected for return; therefore, the procedure likely occurred.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).(b)(4).Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device 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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a patient underwent an open reduction internal fixation (orif) procedure on (b)(6) 2016 to treat a right proximal humerus fracture.Approximately three (3) weeks post-operative, the implanted proximal humeral internal locking system (philos) plate and the locking screws failed in the humeral head portion of the plate.Per the reporter, nine (9) screws laterally backed out of the plate.As a result, a revision procedure to remove the original hardware and implant a new system was required.Details pertaining to the completion of the procedure are unknown.This report is 1 of 2 for (b)(4).

• Brand Name: 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5526018
• MDR Text Key: 41152626
• Report Number: 2520274-2016-11823
• Device Sequence Number: 1
• Product Code: KTW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK011815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 241.903S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention