MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/57MM; PLATE, FIXATION, BONE

Model Number	241.351
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Event occurred on an unknown date in 2017.Device is not expected to return.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the patient underwent hardware removal of an olecranon plate construct on (b)(6) 2017 due to infection.The patient had presented to operating room (or) on (b)(6) 2017 for a grade 2 open comminuted olecranon fracture and a medial epicondyle avulsion.All removed hardware was intact.The distal humerus hardware remains implanted.The surgeon stated that the infection was most likely due to an open wound and patient hygiene issues.Procedure was completed successfully with no surgical delay and no additional medical intervention.Patient was listed as stable post-operatively.(b)(4).
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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 patient had nonunion and delayed healing.

• Brand Name: LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/57MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7127980
• Report Number: 2939274-2017-50343
• Device Sequence Number: 1451015
• Product Code: HRS
• UDI-Device Identifier: 10886982166852
• UDI-Public: (01)10886982166852(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K011335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2017

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: 241.351
• Device Catalogue Number: 241.351
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 01/16/2018; 01/18/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 01/16/2018; 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 YR
• Patient Weight: 134