MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL NAIL RETRO; PROSTHESIS, TRAUMA

Catalog Number 14-444342

Device Problems Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: part#14-442019 lot#unk.Part#14-442021 lot#unk.Part#14-442088 lot#unk.Part#29407 lot#unk.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It has been reported patient underwent surgery approximately three (3) weeks ago.While doctor was inserting nail, the nail came off of the inserter jig.Doctor extracted nail, attempted to reattach it, and it came off again.Doctor then screwed the core lock all the way down hoping it would create more room for the connecting bolt, but the nail still would not attach properly to the jig.Sales rep brought a second set of instruments into the room to see if there was a possible problem with the bolt or jig.He tried using the second set of instruments and the nail would still not attach properly.Doctor ended up using a different nail and it had attached perfectly and was able to be implanted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Event Description

No further event information available at the time of this report.

• Brand Name: FEMORAL NAIL RETRO
• Type of Device: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10025601
• MDR Text Key: 189899670
• Report Number: 0001825034-2020-01870
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00888480166993
• UDI-Public: (01)00888480166993
• Combination Product (y/n): N
• PMA/PMN Number: K072161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-444342
• Device Lot Number: 582190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Age: 37 YR