MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP MEDL DSTL HUMERUS PL 4H/LT/108MM-LONG; PLATE, FIXATION, BONE

Model Number	02.117.504
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Synthes sales rep.(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.The investigation could not be completed; no conclusion could be drawn, as no product was received.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on unknown date, a patient underwent revision with a 3.5 mm distal humerus extra articular plate 8 holes and 8 screws due to non-union.The patient had hardware removal of the following devices: two (2) variable angle elbow plate, one (1) unknown 3.5 locking screw, five (5) unknown 3.5 cortex screw, two (2) unknown 2.7 mm metaphyseal screw , four (4) unknown 2.7 va locking screw, and one (1) unknown 2.7 cortex screw.It was unknown if there was surgical delay.The removal and procedure went well.Patient outcome was fine.This complaint involves seven(7) devices.This report is for one (1) 2.7mm/3.5mm va-lcp medl dstl.This report is 1 of 7 for (b)(4).

• Brand Name: 2.7MM/3.5MM VA-LCP MEDL DSTL HUMERUS PL 4H/LT/108MM-LONG
• 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: 8226406
• Report Number: 2939274-2019-55740
• Device Sequence Number: 262998
• Product Code: HRS
• UDI-Device Identifier: 10886982036780
• UDI-Public: (01)10886982036780
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K120070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/13/2018

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: 02.117.504
• Device Catalogue Number: 02.117.504
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 01/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR