MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN AFFIXUS NAIL; ROD, FIXATION

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Arrest (1762)

Event Type  Death  

Manufacturer Narrative

(b)(4).Multiple mdr's were submitted for this event.Please see reports: 0001825034 - 2017 - 08920.0001825034 - 2017 - 08921.0001825034 - 2017 - 08922.0001825034 - 2017 - 08923.Concomitant products: unknown trauma screw.Report source : foreign.The event(s) occurred in (b)(6).¿surgical delay as a risk factor for wound infection after a hip fracture.¿ injury, elsevier, 28 sept.2016, www.Sciencedirect.Com/science/article/pii/s0020138316306076.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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

Fifteen 15 cases of cardiac failure as a mortality medical complication were reported in the study.No further information has been made available.

Manufacturer Narrative

(b)(4).Upon reassessment of the reported event, it was determined to not be reportable as this device was not involved in the event.The initial report was submitted in error and should be voided.

• Brand Name: UNKNOWN AFFIXUS NAIL
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6961585
• MDR Text Key: 89721319
• Report Number: 0001825034-2017-08920
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other