MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT

Model Number	241.903
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient case number reported as (b)(6).It is unknown when plate broke.Lot number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and 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.(b)(4).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 (b)(6) 2018, the patient underwent revision surgery to remove a broken locking compression plate (lcp) proximal humerus plate 5 hole.The hardware was removed and the patient was revised to a longer lcp proximal humerus plate.The patient was originally implanted with the lcp proximal humerus plate 5 hole on (b)(6) 2018, and after repeated falls, the plate broke.It was unknown if there was a surgical delay.Patient outcome is unknown.This report is for a 3.5mm lcp® proximal humerus plate-standard 5h shaft/114mm.This is report 1 of 1 for (b)(4).

• Brand Name: 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7691197
• Report Number: 2939274-2018-52900
• Device Sequence Number: 11455936
• Product Code: KTW
• UDI-Device Identifier: 10886982167637
• UDI-Public: (01)10886982167637
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K011815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/22/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 241.903
• Device Catalogue Number: 241.903
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2018
• Initial Report FDA Received Date: 07/16/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention