MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN 130 DEG 11MM X 180MM ROD, FIXATION

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that while attempting to move the set screw the set screw became stuck in the nail, and the product could not be used. The set screw was used to move the lock down on the a. R. And log screws. However, this could not be done as the set screw became stuck in the nail while moving it with the hex driver. Subsequently, the nail was removed. Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed. Device history record was reviewed and no discrepancies relevant to the reported event were found. Root cause was unable to be determined. A summary of the investigation has been sent to the complainant. 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

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

• Brand Name: HFN 130 DEG 11MM X 180MM
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7478886
• MDR Text Key: 107067673
• Report Number: 0001825034-2018-03083
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: PK100238
• 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: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 814511180
• Device Lot Number: 107580
• Other Device ID Number: (01) 00887868039102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 05/02/2018 Patient Sequence Number: 1