MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/400MM/LT-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.003.561S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.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.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) 2021, patient underwent a hardware removal of adult lateral entry femoral nail (alefn) due to patient complaining of pain.Procedure was completed successfully without surgical delay.This report involves one (1) 12mm ti lateral entry femoral recon nail-ex/400mm/lt-sterile.This is report 1 of 5 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.H6: manufacturing location: monument, manufacturing date: october 18, 2010, expiration date: september 30, 2019, part: 04.003.561s, 12mm ti lateral entry femoral recon nail-ex/400mm/lt, lot: 6502423 (non-sterile).Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process acceptance met all inspection acceptance criteria.Inspection sheet, inspect dimensional met all inspection acceptance criteria.Inspection sheet, final inspection met all inspection acceptance criteria.Packaging label log lppf was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Sterilization control number (scn) supplied by sterigenics was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.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.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: 12MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/400MM/LT-STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11700341
• Report Number: 2939274-2021-01985
• Device Sequence Number: 17014570
• Product Code: HSB
• UDI-Device Identifier: 10886982082480
• UDI-Public: (01)10886982082480
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K040336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: 09/30/2019
• Device Model Number: 04.003.561S
• Device Catalogue Number: 04.003.561S
• Device Lot Number: 6502423
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 05/18/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: 5.0 MM LOCKING; UNK - SCREWS: 5.0 MM LOCKING; UNK - SCREWS: 5.0 MM LOCKING; UNK - SCREWS: 5.0 MM LOCKING; UNK - SCREWS: 5.0 MM LOCKING; UNK - SCREWS: 5.0 MM LOCKING; UNK - SCREWS: 5.0 MM LOCKING; UNK - SCREWS: 5.0 MM LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR