MAUDE Adverse Event Report: UNK - NAILS: RAFN; ROD, FIXATION, INTRAMEDULLARY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Pma/510k: this report is for an unknown nails: rafn/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.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 an unknown date, the patient was implanted with an expert retrograde/antegrade femoral nail to treat a femoral shaft fracture.After implantation, it was unknown if there was a bone union.Patient had postoperative anemia and hematoma.Patient outcome is unknown.No further information is available.This report is for one (1) unk - nails: rafn.This is report 1 of 4 for (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: updated data: g1, g2.E1: additional contact information for initial reporter.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.H11: corrected data: g4: awareness date reported on initial report as july 06, 2020 but should have been august 18, 2020.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: UNK - NAILS: RAFN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• MDR Report Key: 10432041
• MDR Text Key: 203724070
• Report Number: 2939274-2020-03683
• 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: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2020
• Patient Sequence Number: 1
• Treatment: UNK - END CAPS: RAFN; UNK - NAIL HEAD ELEMENTS: RAFN SPIRAL BLADE; UNK - SCREWS: LOCKING; UNK - END CAPS: RAFN; UNK - NAIL HEAD ELEMENTS: RAFN SPIRAL BLADE; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR