MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE; NAIL,FIXATION,BONE

Model Number	04.004.249S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.Date of event is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record review was performed for the subject device: please note, this dhr review is for sterilization procedure only: part no.: 04.004.249s, lot no.: 7245857.Manufacturing location: (b)(6).Supplier: (b)(6).Release to warehouse date: 20.Mar.2013.Expiry date: 01.Mar.2023.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Non-sterile 04.004.249 / 7245857 was manufactured in us, monument.Manufacturing location: monument.Manufacturing date: 08-feb-2013.Part #: 04.004.249, lot#: 7245857 ¿ 8mm ti cannulated tibial nail-ex/345mm.Quantity 1.Component parts reviewed: part 04.004.249s, bp24 lot: 6630127 reviewed, it meet specification.Lot was reworked from old part 04.004.249s old lot no: 6630127 to new part 04.004.249 new lot: 7245857.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 on (b)(6) 2017 the patient was presented with a left tibia and fibula fracture.The surgeon placed one lcp one-third tubular plate in the patient with seven (7) cortical screws and one partially threaded cancellous screw.She also inserted an 8mm ti cannulated tibial nail with two (2) locking screws (one distal and one proximal).In (b)(6) 2018, the patient presented a non-union of the left tibia and fibula.On (b)(6) 2018 the surgeon removed the lcp one-third tubular plate and the proximal locking screw to promote healing.The surgery was completed with no delays and there was not harm to the patient.This is report 4 of 5 for (b)(4).

• Brand Name: 8MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE
• Common Device Name: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7425032
• Report Number: 2939274-2018-51611
• Device Sequence Number: 159377
• Product Code: JDS
• UDI-Device Identifier: 10886982083654
• UDI-Public: (01)10886982083654(17)230301(10)7245857
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• 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): 03/21/2018

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 Expiration Date: 03/01/2023
• Device Model Number: 04.004.249S
• Device Catalogue Number: 04.004.249S
• Device Lot Number: 7245857
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 04/12/2018
• 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
• Patient Age: 26 YR