MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAILS: TFNA; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Calcium Deposits/Calcification (1758); Pain (1994)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event is an unknown date in 2019.This report is for an unknown tfna nail/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, a patient underwent an unknown procedure to treat a fracture with the trochanteric fixation nail advanced (tfna) system.Reportedly, on (b)(6) 2019, the patient presented with mild distal ossification of intramedullary nail which is ongoing and unchanged.Concomitant devices: tfna helical blade (part: unknown, lot: unknown, quantity, 1).This report is for an unknown tfna nail.This is report 1 of 2 (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: b5: updated event description.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

Device report from china reports an event as follows: it was reported that on (b)(6) 2019, a patient underwent an unknown procedure to treat a fracture with trochanteric fixation nail advanced (tfna) system.On (b)(6) 2019, the patient experienced moderate post-operative incision pain.Reportedly, on (b)(6) 2019, the patient presented with mild distal ossification of intramedullary nail which is ongoing and unchanged.The reported incision pain is ongoing with improvement.Concomitant devices: tfna helical blade (part: unknown, lot: unknown, quantity, 1).This complaint involves two (2) devices.This report is for an unknown tfna nail.This is report 1 of 2 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.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

Updated event description:it was reported that on (b)(6) 2019, a patient underwent an unknown procedure to treat a fracture with trochanteric fixation nail advanced (tfna) system.On (b)(6) 2019, the patient experienced moderate post-operative incision pain.Reportedly, on (b)(6) 2019, the patient presented with mild distal ossification of the intramedullary nail which was resolved without sequela on (b)(6) 2019.The reported incision pain was resolved without sequela on (b)(6) 2019.Concomitant devices: tfna helical blade (part: unknown, lot: unknown, quantity, 1).

• Brand Name: UNK - NAILS: TFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9124332
• MDR Text Key: 165389601
• Report Number: 8030965-2019-68732
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• 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: 01/13/2020
• Patient Sequence Number: 1
• Treatment: UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR