MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 130, LEFT, 10 MM, 18 CM; CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT 10MM X 18CM 130 CCD LEFT TI-6AL-4V

Model Number N/A

Device Problem Connection Problem (2900)

Patient Problem No Code Available (3191)

Event Date 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

During surgery, cmn femoral nail couldn't connect the cm targeting guide.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Investigation and conclusion: harm: extended surgery time 15min = t = 30min.Hazard: does not assemble.No relevant medical data has been received.Visual examination: the nail was returned for investigation.The znn nail is damaged at the connection area.It can be assumed that this was occurred while inserting the znn nail onto the targeting guide.Review surgical technique: the coorect nail insertion is described.Nail assembly and insertion: the color code for the cephalomedullary nail is blue.Ti-6al-4v alloy nails, the targeting guide and the connecting bolt all have blue colors on them, as well as the word blue on them.The targeting guide asia can be used for asia and long nails.Place the connecting bolt through the barrel of the targeting guide.The arrow on the nail (with an r for a right nail or an l for a left nail) will line up with the arrow on the barrel of the guide when the nail is correctly aligned.Begin threading the connecting bolt (by hand or using the connecting bolt inserter) into the proximal portion of the nail.Orient the proximal portion of the nail so that the slots in the nail match up with the corresponding tines on the barrel of the targeting guide.Completely tighten the connecting bolt using the connection bolt inserter to secure the nail to the guide.The product is intended for treatment.The investigation results did not identify a non-conformance or a complaint out of box (coob).Based on the available information and performed investigation, an exact root cause could not be determined.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Please refer to report 0009613350-2019-00368.

• Brand Name: CMN FEMORAL NAIL, CCD 130, LEFT, 10 MM, 18 CM
• Type of Device: CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT 10MM X 18CM 130 CCD LEFT TI-6AL-4V
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8685955
• MDR Text Key: 147596674
• Report Number: 0009613350-2019-00368
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K120715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-183-10
• Device Lot Number: 2949607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/17/2019
• Initial Date FDA Received: 06/11/2019
• Supplement Dates Manufacturer Received: 03/17/2020
• Supplement Dates FDA Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1