MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP PLATE 8 HOLES 111MM; PLATE,FIXATION,BONE

Model Number	223.581
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight was not provided for reporting.Date of event is unknown.Additional device code: hwc, ktt.Date of implant is unknown.Device is not expected to be returned for manufacturer review/investigation.Reporter contact number was not provided for reporting.(b)(4) used to capture additional medical/surgical intervention required.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 (b)(6) 2017, patient underwent revision surgery due to unhealed fracture.A small plate and six unknown screws implanted on an unknown date were removed from the ulna and it was replaced with a longer plate.All the removed parts were intact.The procedure was completed successfully and there was no surgical delay.Patient was stable after the surgery.This report is for one (1) 3.5mm lcp plate 8 holes 111mm.This is report 1 of 2 for (b)(4).

• Brand Name: 3.5MM LCP PLATE 8 HOLES 111MM
• 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: 7122394
• Report Number: 2939274-2017-50315
• Device Sequence Number: 19239847
• Product Code: HRS
• UDI-Device Identifier: 10886982157959
• UDI-Public: (01)10886982157959(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2017

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: 223.581
• Device Catalogue Number: 223.581
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 12/15/2017
• 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