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¿s gender and weight are unknown.Date of event: unknown.Additional device product codes: hwc, ktt.Complainant device is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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 midshaft humeral fracture fixation had failed and a revision surgery was performed on (b)(6) 2017.The original surgery was performed on (b)(6) 2017.There was failure of fracture reduction.A total of nine (9) implanted devices which include eight (8) cortex screws and one (1) plate was removed.All implants were intact and did not have any issues.The patient was revised to two (2) plates and eleven (11) screws which were a combination of cortical and locking screws.The revision surgery was completed without any delay and the patient was reported to be in stable condition.This report is for one (1) 3.5mm lcp plate 8 holes 111mm.This is report 1 of 2 for complaint (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: 7138451
• Report Number: 2939274-2017-50394
• Device Sequence Number: 11030122
• Product Code: HRS
• UDI-Device Identifier: 10886982157959
• UDI-Public: (01)10886982157959(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2017

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: 11/27/2017
• Initial Report FDA Received Date: 12/21/2017
• 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