MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.013.656S
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.(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) 2019, the patient underwent revision surgery for the removal of retrograde/antegrade femoral nail (rafn) from femur due to nonunion.Originally, the rafn nail and four (4) locking screws was implanted on (b)(6) 2018.The patient was reamed and a larger nail was inserted.All hardware were intact.There was no surgical delay and the procedure was successfully completed.Patient status is stable.This report is for one (1) 12 mm ti cann retro/antegrade femoral nail-ex/380 mm-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.Additional product code hwc.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.
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.Sterile part 04.013.656s, lot h641203: manufacturing location: monument.Manufacturing date: may 22, 2018.Expiration date: april 30, 2027.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.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.
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 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
This is report 1 of 5 for (b)(4).

• Brand Name: 12MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-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: 8816316
• Report Number: 2939274-2019-59313
• Device Sequence Number: 16779338
• Product Code: HSB
• UDI-Device Identifier: 10886982088222
• UDI-Public: (01)10886982088222
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/27/2019

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: 04.013.656S
• Device Catalogue Number: 04.013.656S
• Device Lot Number: H641203
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 06/27/2019; 08/23/2019; 08/23/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 07/23/2019; 08/23/2019; 08/23/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Weight: 143