MAUDE Adverse Event Report: SYNTHES ELMIRA 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/RT/90MM; PLATE,FIXATION,BONE

Model Number	02.107.202
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Discomfort (2330); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant device is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was requested for part 02.107.202/ lot 698574: no dhr review can be completed since the lot number provided is inaccurate or incomplete.Lot 698574 does not exist in the synthes erp (jde) system.(b)(4).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 on an unknown date the patient was implanted with one (1) 2.7mm/3.5mm variable angle locking compression plate (lcp) olecranon plate, one (1) unknown 3.5mm locking screw, one (1) unknown 3.5mm cortical screw and four (4) unknown 2.7 mm locking screws as treatment for a right olecranon fracture.On an unknown date post-operatively, the patient decided he wanted his hardware removed due to being uncomfortable.No allegations were reported against the hardware.It is unknown if there were any contributing factors that lead up to the adverse event.The patient underwent revision surgery on (b)(6) 2017 for hardware removal.This report addresses postoperative issue of patient being uncomfortable.The intraoperative issues of difficulty in removing four (4) 2.7mm unknown locking screws during the hardware removal surgery has been reported under linked complaint (b)(4).This report is for one (1) 2.7mm/3.5mm va-lcp olecranon plate.This is report 1 of 4 for complaint (b)(4).

• Brand Name: 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/RT/90MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6804058
• Report Number: 3003506883-2017-10169
• Device Sequence Number: 983803
• Product Code: HRS
• UDI-Device Identifier: 10886982029263
• UDI-Public: (01)10886982029263(10)698574
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.107.202
• Device Catalogue Number: 02.107.202
• Device Lot Number: 698574
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 08/18/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 120