MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM NARROW LCP® PLATE 9 HOLES/170MM; PLATE,FIXATION,BONE

Model Number	224.591
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event in unknown.Additional product code hwc ktt.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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) 2020, the patient underwent a removal procedure due to a non-union of the mid-shaft humerus.During the procedure the 9-hole 4.5 narrow locking compression plate (lcp) and all of its eight (8) 4.5mm cortical screws were explanted.Also removed during the procedure was the 2.7 8-hole straight locking compression plate (lcp) and all of its six (6) 2.7 cortical screws.It is unknown what device was the patient revised to after the original implants were removed.It is unknown if there was a surgical delay.Patient status and surgical outcome were unknown.This report is for (1)4.5mm narrow lcp® plate 9 holes/170mm.This is 2 of 10 for report (b)(4).Related product complaint: (b)(4).

• Brand Name: 4.5MM NARROW LCP® PLATE 9 HOLES/170MM
• 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: 9793769
• Report Number: 2939274-2020-01142
• Device Sequence Number: 16787895
• Product Code: HRS
• UDI-Device Identifier: 10886982158529
• UDI-Public: (01)10886982158529
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2020

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: 224.591
• Device Catalogue Number: 224.591
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 03/05/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 YR