MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LOCKING ATTACHMENT PLATE FOR 4.5MM LCP PLATE/4 HOLES; PLATE,FIXATION,BONE

Model Number	02.120.601
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient age was not available for reporting.Unknown when infection began.Complainant part is not expected to be returned for manufacturer review/investigation.There is no allegation of a product malfunction against this device; however, because this device is dwelling in the area of the reported event it cannot be disassociated from the reported adverse event.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.Product was not returned and no lot number was provided.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 the patient underwent removal of two 3.5 mm attachment plates ,five 5.0 mm locking screws, four cables, one plate and eight 3.5 mm locking screws on (b)(6) 2018 due to infection.A pus came out when patient was opened.A removal and debridement were performed.The hardware was originally implanted on (b)(6) 2013.The revision surgery was completed without any complications and without any surgical delay.Patient status following the procedure was reported as stable.This complaint involves six (6) devices.This report is 6 of 6 for (b)(4).

• Brand Name: 3.5MM LOCKING ATTACHMENT PLATE FOR 4.5MM LCP PLATE/4 HOLES
• 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: 7375113
• Report Number: 2939274-2018-51255
• Device Sequence Number: 1393492
• Product Code: HRS
• UDI-Device Identifier: 10886982040084
• UDI-Public: (01)10886982040084(10)LOTUNK
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K083573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2018

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: 02.120.601
• Device Catalogue Number: 02.120.601
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 03/27/2018
• 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