MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7 MM VA-LCP LAT DIS FIB 5H L; PLATE, FIXATION, BONE

Model Number	02.118.405
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Event date unknown when drainage of wound began.Additional product code: hwc.The patient was reported to have wound drainage requiring revision surgery.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.
Event or Problem Description
It was reported that a patient had a hardware removal on (b)(6) 2018 due to a draining wound.It is unknown when the devices were implanted.It is unknown if there was a surgical delay.Patient and surgical outcome is unknown.This complaint involves eight (8) devices.This is report 8 of 8 for (b)(4).

• Brand Name: 2.7 MM VA-LCP LAT DIS FIB 5H L
• 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: 7924076
• Report Number: 2939274-2018-54037
• Device Sequence Number: 1653579
• Product Code: HRS
• UDI-Device Identifier: 10886982038883
• UDI-Public: (01)10886982038883
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K120854
• 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): 09/05/2018

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: 02.118.405
• Device Catalogue Number: 02.118.405
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/01/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR