MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 130, LEFT, 10 MM, 21.5 CM

Model Number N/A

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 11/15/2017

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The device was received, the investigation is pending.As no lot number was provided, the device history records could not be reviewed.Additional information has been requested and is currently not available.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

It was reported that the patient was implanted a cmn femoral nail, ccd 130, left, 10 mm, 21.5 cm on left side on (b)(6) 2017 and the patient underwent revision surgery (b)(6) 2017 due to implant breakage.

Manufacturer Narrative

Concomitant medical products: ref.No# 47-2484-035-50 , lot no# unknown, name:5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head; ref.No# 47-2485-1101-0 , lot no# 2894800, name: znn cmn lag screw, 10.5 mm, 110 mm including set screw.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: revision surgery due to fractured nail.Review of event description : it was reported that the znn nail fractured after approximately 4 months in vivo.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents were received.Devices analysis: visual examination: the fractured znn nail, a lag screw and one screw were returned for investigation.The visual examination shows that the nail fractured through the lag screw hole.The fracture surfaces on both fracture parts are characterized by beach lines which points to a fatigue fracture.The fracture originates from the lateral side (lag screw entry side) of the hole.As far as visible no defects that could have triggered the fracture could be detected on the fracture surfaces.Coarse scratches can be observed on the fractured znn nail which most likely derived from the revision surgery.On both fracture parts the hole for the lag screw shows drilling traces, pronominally on the anterior side.Due to this a new edge has been created located at the fracture origin (lag screw entry side).Contact areas between the nail and the lag screw (distal medial and proximal lateral) exhibit marks indicating lag screw movements which are overlaying the drilling traces.On both fracture parts metal wear can be observed on an edge of the lag screw hole and drilling damage.Therefore, the latter could be ascribed to the implantation surgery.On the lag screw fine spiraled scratches from screwing in and/or out can be observed.The lag screw shows areas of contact with set screw and/or the nail in between the grooves.The cortical screw is inconspicuous.Conclusion summary: it was reported that the znn nail fractured after approximately 4 months in vivo.The visual examination of the fracture surfaces points to a fatigue fracture.Macroscopically, as far as visible, no defects that could have triggered or favored the fracture could be found on the fracture surfaces.However, drilling traces were observed on both fracture parts at the fracture origin (lag screw entry side).It could be assumed that the fracture occurred due to an overload.It stays unknown if the drilling traces could have triggered or favored the fracture.Based on the received information and the retrieval investigation an exact root cause for the fracture of the znn nail 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).

• Brand Name: CMN FEMORAL NAIL, CCD 130, LEFT, 10 MM, 21.5 CM
• Type of Device: CMN FEMORAL NAIL
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7137262
• MDR Text Key: 95452290
• Report Number: 0009613350-2017-01761
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: PK091566
• 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: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-213-10
• Device Lot Number: 2908811
• Other Device ID Number: 00889024298958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Date Manufacturer Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention