MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN 130 DEG 13MM X 180MM; ROD, FIXATON

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product- hfn 130 deg 13mm x 180mm catalog#:814513180 lot#:404170.(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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 09668.

Event Description

It is reported that during a procedure the surgeon attempted to implant the screw, however, it did not advance correctly as it jammed.Therefore, another screw was opened used to complete the procedure.Additionally , the second screw also malfunction/jammed, however, the surgeon decided to leave the nail in the patient as it was already implanted.Attempts have been made for additional information, however, none is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 is reported that during a procedure the surgeon attempted to implant the screw, however, it did not advance correctly as it jammed.Therefore, another screw was opened used to complete the procedure.Additionally, the second screw also malfunction/jammed, however, the surgeon decided to leave the nail in the patient as it was already implanted.Due to this malfunction, a one hour delay was reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of a returned device of a different lot.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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 additional information received.

• Brand Name: HFN 130 DEG 13MM X 180MM
• Type of Device: ROD, FIXATON
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7958267
• MDR Text Key: 123510566
• Report Number: 0001825034-2018-09664
• 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: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• 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: 814513180
• Device Lot Number: 970510
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-3132-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other