MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; ROD, FIXATION, INTRAMEDULLARY

Device Problem Migration (4003)

Patient Problem No Code Available (3191)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event is an unknown date in 2018.This report is for an unknown tfna helical blade/unknown lot.Part and lot number are unknown; udi number is unknown.Date of implantation is an unknown date in (b)(6) 2018.Complainant part is not expected to be returned for manufacturer review/investigation.Date of concomitant therapy is the same as date of implantation; an unknown date in (b)(6) 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 Description

It was reported that on (b)(6) 2018, a trochanteric fixation nail advanced (tnfa) helical blade has cut/gone into the acetabulum.A couple of x-rays were sent from the surgeon stating that the x-rays are of a patient's hip.Original implantation date was sometime in (b)(6) 2018.On (b)(6) 2018, the patient was revised to a total hip prosthesis.The tfna implants were removed easily with no problems.Patient status is unknown.Concomitant devices: locking screw (part: unknown, lot: unknown, quantity: unknown), tfna nail (part: unknown, lot: unknown, quantity: 1).This report is for an unknown tfna helical blade.This is report 1 of 1 for(b)(4).

Manufacturer Narrative

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.

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.A product investigation was completed: actual device was not returned.Visual inspection of the provided x-ray confirmed the condition of post cut-out of femoral head, which agrees with the reported complaint condition.The x-ray shows that the helical blade has penetrated the acetabulum.A review of the device history records was unable to be performed since the lot number was unknown.The relevant drawing was reviewed during this investigation.No product design issues or discrepancies were observed during this investigation.This complaint condition is adequately covered by the risk assessment.A definitive root cause for the event could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation and this complaint condition is adequately covered by the risk assessment.No new, unique or different patient harms were identified as a result of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8199014
• MDR Text Key: 131483175
• Report Number: 2939274-2018-55596
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2018

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/27/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 12/27/2018; 01/21/2019
• Supplement Dates FDA Received: 12/27/2018; 01/24/2019
• Patient Sequence Number: 1
• Treatment: SEE EVENT DESCRIPTION
• Patient Outcome(s): Required Intervention