MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AFFIXUS 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 06/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products- hfn 130 deg 11mm x 180mm catalog#: 814511180 lot#: 944660, hfn 130 deg 11mm x 180mm catalog#: 814511180 lot#: 901380.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.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.Multiple mdr reports were filed for this event, please see associated reports:0001825034-2018-04612, 0001825034-2018-04614.

Event Description

It was reported that during a hip fracture nailing procedure, while the operating surgeon was attempting to implant the lag screw, the set screw was unable to advance.The surgeon then had to remove everything and was still unable to move the set screw.Two (2) more nails were opened and tested, and these set screws also would not advance.The surgery was later successfully completed with a new nail.No additional patient consequences were reported.

Event Description

It was reported that during a hip fracture nailing procedure, while the operating surgeon was attempting to implant the lag screw, the set screw was unable to advance.The surgeon then had to remove everything and was still unable to move the set screw.Two (2) more nails were opened and tested, and these set screws also would not advance.The surgery was later successfully completed with a new nail.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).Complaint sample was evaluated and the reported event was confirmed.All three nails were returned and evaluated.The event of jammed set screws was confirmed.Dhr was reviewed and no discrepancies were found root cause was unable to be determined.Corrective action has been initiated to further address the event 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.

• Brand Name: AFFIXUS 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: 7777965
• MDR Text Key: 116931504
• Report Number: 0001825034-2018-04611
• 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
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• 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: 814511180
• Device Lot Number: 901300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR