MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/400MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.013.560S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Impaired Healing (2378); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of nonunion is unknown.Additional procode: hwc.Date of implantation is an unknown date in (b)(6) 2018.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review has been requested.(b)(4).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) 2018, the patient underwent removal of a titanium cannulated retro/antegrade femoral nail and (3) unknown screws due to non-union.The hardware was originally implanted on an unknown date in (b)(6) 2018 as a second surgery.No details on the first surgery have been provided.During the procedure, the extractor did not work, and another set was opened to complete the procedure.The removal was successfully completed.It is unknown if there was any surgical delay.Patient outcome is unknown.This report addresses the post-operative event of hardware removal due to non-union.The intra-operative event has been reported under linked complaint (b)(4).This report is for a 11mm titanium (ti) cannulated retrograde/antegrade femoral nail-ex/400mm-sterile.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device history record (dhr) review: manufacturing location: monument; manufacturing date: november 18, 2016; expiration date: october 31, 2025; part number: 04.013.560s, 11mm ti cann retro/antegrade femoral nail-ex/400mm ¿ sterile, lot number: h236354 (sterile); lot quantity (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, inprocess / inspect dimensional / final met all inspection acceptance criteria.Packaging label log was reviewed and determined to be conforming.Packaging bom was reviewed and all components issued met current defined requirements.Scn 13182 supplied by (b)(4) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterilization and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component(s) reviewed: part number: 21012, tialnbri13.00, lot number: h100123; lot quantity: (b)(4).Certified test report received from perryman company dated november 12, 2015 was reviewed and determined to be conforming.Lot summary report dated may 05, 2016 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.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.

• Brand Name: 11MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/400MM-STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7841740
• Report Number: 2939274-2018-53575
• Device Sequence Number: 19469818
• Product Code: HSB
• UDI-Device Identifier: 10886982088062
• UDI-Public: (01)10886982088062
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K033618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2018

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: 10/31/2025
• Device Model Number: 04.013.560S
• Device Catalogue Number: 04.013.560S
• Device Lot Number: H235354
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 10/01/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR