MAUDE Adverse Event Report: SYNTHES GMBH 12MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/340MM-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.013.648S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Additional device product code: hwc complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(6) as follows: it was reported that during a procedure on an unknown date, the retrograde nail locking screws were placed outside the locking holes.This was rectified during check x-rays in theatre, the surgeons used free hand technique to do the distal femoral locking of the distal femur of the patient.There was thirty (30) minutes surgical delay.The procedure was completed successfully.The patient outcome is reported as stable.No further information provided.This report is for one (1) 12mm ti cann retro/antegrade femoral nail-ex/340mm-sterile.This is report 2 of 3 for complaint (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.Investigation summary - product was not returned.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 history lot - a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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: 12MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/340MM-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12349134
• MDR Text Key: 267518901
• Report Number: 8030965-2021-06967
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819834965
• UDI-Public: (01)07611819834965
• Combination Product (y/n): N
• PMA/PMN Number: K033618
• 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: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2024
• Device Catalogue Number: 04.013.648S
• Device Lot Number: 9091322
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2021
• Initial Date FDA Received: 08/20/2021
• Supplement Dates Manufacturer Received: 09/21/2021
• Supplement Dates FDA Received: 09/21/2021
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: LOCKING (QTY 2); UNK - SCREWS: LOCKING (QTY 2)