MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM TI CANNULATED TIBIAL NAIL-EX/375MM-STERILE; NAIL,FIXATION,BONE

Model Number	04.004.555S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Date of event is unknown.Date of implant is unknown.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device history records review was completed for part# 04.004.555s, lot# 6826662.Manufacturing location: monument, manufacturing date: dec 05, 2011, expiry date: oct 31, 2020.No non- conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Component parts reviewed: part 21012 bp80 lot: 6706312 reviewed.Raw material for titanium received from supplier perryman company.Certificate of test for titanium ingot received from perryman meets specification.Raw material receiving/putaway checklist meets requirements.Inspection sheet for in-process acceptance meet specification.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 an unknown date, patient underwent initial surgery for the insertion of a tibial nail.Post-operative, patient had bone infection and non-union.A hardware removal and revision surgery was performed on (b)(6) 2018.An 11 mm ti cannulated tibial nail and four (4) 5.0 mm ti locking screws were removed successfully and all intact.The revision surgery entailed the insertion of an antibiotic nail until the bone infection clears and will eventually be replaced with another tibial nail.There were no surgical delays, surgery was completed successfully and the patient outcome was reported as stable.This report is for one (1) 11 mm ti cannulated tibial nail-ex/375 mm-sterile.This is report 1 of 5 for (b)(4).

• Brand Name: 11MM TI CANNULATED TIBIAL NAIL-EX/375MM-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: 7402415
• Report Number: 2939274-2018-51497
• Device Sequence Number: 1718003
• Product Code: JDS
• UDI-Device Identifier: 10886982084538
• UDI-Public: (01)10886982084538(17)201031(10)6826662
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2018

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: 10/31/2020
• Device Model Number: 04.004.555S
• Device Catalogue Number: 04.004.555S
• Device Lot Number: 6826662
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 04/06/2018
• 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: 54 YR
• Patient Weight: 108