MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP® POSTEROLATERAL DISTAL HUMERUS PLATE 7H-RIGHT; APPLIANCE,FIXATION,NAIL

Model Number	241.266
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient height reported as (b)(6).Date of non-union is not known.Date of implant/therapy date reported as (b)(6) 2017, exact date is not known.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient was implanted with a 3.5mm locking compression plate (lcp) posterolateral distal humerus plate, 3.5mm cortex screws (quantity of 3), 2.7mm locking screws (quantity of 2) and 3.5mm locking screws (quantity of 4) for an orif (open reduction internal fixation) of a humerus in (b)(6) 2017.A nonunion was noted on an unknown date.X-rays were taken on an unknown date and showed that the (two) 2.7mm locking screws were not connected to the plate.Both screws were stuck in the bone fully intact, causing minimal fixation.The x-rays also showed that the threads on one of the 2.7mm locking screw heads stripped.Patient underwent revision surgery on (b)(6) 2018.All hardware was easily removed.Patient was revised to a variable angle (va) plate, screws and vivigen formable bone grafts.There was no surgical delay.The procedure was completed successfully and the patient was reported as stable.Concomitant devices reported: 3.5mm cortex screw, self-tapping 20mm (part 204.820, lot number unknown, quantity 1); 3.5mm cortex screw, self-tapping 24mm (part 204.824 lot number unknown, quantity 1); 3.5mm cortex screw, self-tapping 28mm (part 204.828 lot number unknown, quantity 1); 3.5mm locking screw, self-tapping with stardrive recess 22mm (part 212.107 lot number unknown, quantity 2) and 3.5mm locking screw, self-tapping with stardrive recess 26mm (part 212.109 lot number unknown, quantity 2).This report is for one (1) 3.5mm lcp posterolateral distal humerus plate.This is report 1 of 3 for (b)(4).
Additional Manufacturer Narrative
Device history records review was completed for part# 241.266, lot# 3217103.Manufacturing location: (b)(4), release to warehouse date: jul 31, 2009.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product 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.

• Brand Name: 3.5MM LCP® POSTEROLATERAL DISTAL HUMERUS PLATE 7H-RIGHT
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7325339
• Report Number: 2939274-2018-50938
• Device Sequence Number: 104354
• Product Code: KTT
• UDI-Device Identifier: 10886982166272
• UDI-Public: (01)10886982166272(10)3217103
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2018

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: 241.266
• Device Catalogue Number: 241.266
• Device Lot Number: 3217103
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 05/01/2018
• 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 Weight: 52