MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14MM/130 DEG TI CANN TFNA 480MM/RIGHT-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.468S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event date: unknown date in 2018.Implant date: unknown date in 2018.Without a lot number the device history records review could not be completed.Product was not returned.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, around two months ago, a patient was implanted with proximal femoral nailing system (tfna) to repair a right femur subtrochanteric fracture.On (b)(6) 2018, patient was evaluated and x-rayed.The x-ray showed a broken nail where the tfna fenestrated screws passes through the nail.Removal and repair was performed on (b)(6) 2018.There was a surgical delay of twenty (20) minutes to remove broken hardware which involved extra radiation from c-arm to ensure hardware was removed.There were no fragments generated from the broken device.It was noted that there was delayed healing and decreased range of motion.Procedure was successfully completed.Concomitant devices reported: tfna fenestrated screw (part#: 04.038.215s, lot#: unknown, quantity: 1), unknown distal locking screw (part # unknown, lot # unknown, quantity unknown).This report is for one (1) 14mm/130 deg ti cann tfna 480mm/right-sterile.This is report 1 of 1 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.Patient's height reported as 185.00 cms.No product was returned; the investigation was performed based upon a review of the received medical images.Upon review of the medical images, it can be confirmed that the nail was broken through the proximal hole.The cause for the broken nail is not able to be determined.The risk documentation was reviewed and found to adequately address the complaint condition.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: 14MM/130 DEG TI CANN TFNA 480MM/RIGHT-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: 7962474
• Report Number: 2939274-2018-54358
• Device Sequence Number: 19225542
• Product Code: HSB
• UDI-Device Identifier: 10886982097729
• UDI-Public: (01)10886982097729
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• 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): 09/27/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.037.468S
• Device Catalogue Number: 04.037.468S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 11/13/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 116