MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 125°, RIGHT, 10 MM, 21.5 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem Failure of Implant (1924)

Event Date 03/08/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The manufacturer received product pictures for review.Device history record (dhr) was reviewed and no discrepancies were found.The following report is associated with this event 0009613350 -2019 - 00204.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 during a surgery, a set screw was stuck when being set and it couldn't be turned.The surgeon had to remove the znn nail and implant a back-up nail.There was a delay in the procedure of more than 30 minutes.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Device history records (dhr): the device manufacturing quality records for ref.47-2493-210-10 indicate that the released components met all requirements to perform as intended.Trend analysis: yes, at least 3 similar investigated events within the last 1 month or at least 6 similar investigated events within the last 6 months prior to the event date have been found for this item number.Event description: it was reported that during a surgery on (b)(6) 2019, a set screw was stuck when being set and couldn't be turned.The surgeon had to remove the znn nail and implant a back-up nail.There was a delay in the procedure of more than 30 minutes.No relevant medical data has been received.Visual examination: the set screw and the znn nail have been returned for investigation.The visual examination shows that the set screw was still inside znn nail.The set screw was removed from the nail.It can be seen the threads of the set screw were polished and damaged.This could possibly be caused by incorrect placement of the set into the nail.The products are intended for treatment.The investigation results did not identify a non-conformance or a complaint out of box (coob).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 125°, RIGHT, 10 MM, 21.5 CM
• Type of Device: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8498485
• MDR Text Key: 141431930
• Report Number: 0009613350-2019-00203
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024298835
• UDI-Public: 00889024298835
• Combination Product (y/n): N
• PMA/PMN Number: K091566
• 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: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-210-10
• Device Lot Number: 2964485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other