MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH FEM RECON NAIL GT Ø12 LE L400 TAN; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.033.271S

Device Problem Break (1069)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 06/01/2019

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.(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

Device report from synthes, reports an event in the (b)(6) as follows: it was reported that, on an unknown date, a patient was admitted experiencing hip pain; upon x-ray, it was noted that the femoral recon nail, (frn) had broken below the top 2 proximal recon screws (6.5 mm recon screws).No fragments were generated.The patient was operated on with the frn being removed and replaced with a tfna augmentation.The original frn implant was implanted in the patient in (b)(6) 2019 by (b)(6) hospital.Concomitant device reported: unknown proximal recon screws (part # unknown, lot # unknown, quantity # 2), unknown locking screws (part # unknown, lot # unknown, quantity # 2).This complaint involves one (1) device.This report is for one (1) 12 mm / ti cann frn / gt 400 mm / left - sterile.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.H3, h6: investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.B3: unknown event date: 2019.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: FEM RECON NAIL GT Ø12 LE L400 TAN
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9486155
• MDR Text Key: 171797414
• Report Number: 8030965-2019-71193
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07612334124722
• UDI-Public: (01)07612334124722
• Combination Product (y/n): N
• PMA/PMN Number: K172157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/29/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.033.271S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 02/05/2020
• Supplement Dates FDA Received: 02/18/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention