MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT

Model Number	241.901
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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/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 that on (b)(6) 2019, the surgeon noticed a coil or shaving of metal that came off the implants when removing a 3.5mm locking screw from a 3.5mm locking compression plate (lcp) proximal humerus plate.The metal shaving was removed and the surgeon replaced the screw with a shorter screw into the humerus.The loose shaving of metal was then disposed.Fragments were generated but easily removed.There was no surgical delay.Procedure was successfully completed.There was no patient consequence.Concomitant devices: unknown 3.5mm locking screw (part # unknown, lot # unknown, quantity # 1), unknown screws (part # unknown, lot # unknown, quantity # unknown).This complaint involves one (1) device.This report is for (1) 3.5mm lcp® proximal humerus plate-standard 3h shaft/90mm.This is report 1 of 1 for (b)(4).

• Brand Name: 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM
• 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: 9411698
• Report Number: 2939274-2019-62482
• Device Sequence Number: 19833423
• Product Code: KTW
• UDI-Device Identifier: 10886982167620
• UDI-Public: (01)10886982167620
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K011815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 241.901
• Device Catalogue Number: 241.901
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/04/2019
• Patient Sequence Number: 1