MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP® PROXIMAL HUMERUS PLATE-LONG 8H SHAFT/196MM; PLATE,FIXATION,BONE

Model Number	241.921
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: (b)(4).Date of event is unknown.(b)(4).Date of implant is an unknown date in (b)(6) 2017.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 in (b)(6) 2017, patient was implanted with proximal humerus plate, 3.5 cortex screws (quantity of 4) and 3.5 locking screws (quantity of 8).Post-operative, patient complained of pain.A physician told the patient the plate was too long so she wanted it removed and wanted to keep hardware.The attending taking it out stated he felt like the plate was appropriate for her fracture and everything looked good.The implants were explanted on (b)(6) 2018.The bone was healed.There was no surgical delay.The patient status was complete/ok.The procedure was completed successfully.This report is for one (1) 3.5mm lcp® proximal humerus plate-long 8h shaft/196mm.(b)(4).

• Brand Name: 3.5MM LCP® PROXIMAL HUMERUS PLATE-LONG 8H SHAFT/196MM
• 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: 7320721
• Report Number: 2939274-2018-50912
• Device Sequence Number: 11164223
• Product Code: HRS
• UDI-Device Identifier: 10886982167682
• UDI-Public: (01)10886982167682(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K041860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2018

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: 241.921
• Device Catalogue Number: 241.921
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 03/07/2018
• 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: 56 YR
• Patient Weight: 71