MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP OLECRANON PL 4H/LT/116MM; PLATE, FIXATION, BONE

Model Number	02.107.304
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.Additional product code: hwc.Device is not expected to return.(b)(4).Device history review is currently in progress.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.This is report 1 of 7 for (b)(4).
Additional Manufacturer Narrative
Dhr review was completed.Part# 02.107.304 lot# 7813813 part mfg date: 07 october 2014 mfg location: (b)(4) synthes part expiration date: n/a nonconformances noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 2.7mm/3.5mm va-lcp olecranon pl 4h/lt/116mm product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture 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.
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: 2.7MM/3.5MM VA-LCP OLECRANON PL 4H/LT/116MM
• 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: 7125318
• Report Number: 2939274-2017-50339
• Device Sequence Number: 13755687
• Product Code: HRS
• UDI-Device Identifier: 10886982029355
• UDI-Public: (01)10886982029355(10)7813813
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K120070
• 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: 02.107.304
• Device Catalogue Number: 02.107.304
• Device Lot Number: 7813813
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 01/17/2018; 01/18/2018
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 01/17/2018; 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