MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP PLATE 10 HOLES 137MM; PLATE,FIXATION,BONE

Model Number	223.601
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 id and weight were not provided for reporting.Date of event is unknown.Additional device codes: hwc and ktt.Implanted date: unknown.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, 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 an unknown date, patient was implanted with a locking compression plate (lcp) and six (6) cortex screws.On (b)(6) 2018, patient underwent revision surgery due to non-union of an ulna.During the procedure, it was observed that around 15mm piece of bone was missing from the non-union site.The lcp plate and six cortex screws were then removed.A 10-hole locking compression plate (lcp) plate was removed along with six (6) 3.5 cortex screws.Implants were removed intact.A new 12-hole 3.5 lcp plate and 3.5 locking and cortex screws were placed in the patient.A 15mm piece of tricortical bone from patient¿s iliac crest was used to replace missing bone from ulna.The procedure was completed successfully with no surgical delay.There was less than desirable treatment outcome reported due to non-union.Patient outcome was good.This report is for one (1) 3.5mm lcp plate 10 holes 137mm.This is report 1 of 2 for (b)(4).

• Brand Name: 3.5MM LCP PLATE 10 HOLES 137MM
• 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: 7638914
• Report Number: 2939274-2018-52634
• Device Sequence Number: 16533027
• Product Code: HRS
• UDI-Device Identifier: 10886982157997
• UDI-Public: (01)10886982157997
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 223.601
• Device Catalogue Number: 223.601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/26/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR