MAUDE Adverse Event Report: ZIMMER INC UNKNOWN ZIMMER HUMERAL NAIL; TRAUMA PROSTHESIS

Device Problem Difficult to Insert (1316)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

(b)(4).No physical product or photographs are available for evaluation.Device history records and inspection reports cannot be reviewed since the lot number is unknown.The device was used for treatment.A definitive root cause cannot be determined with the information provided.

Event Description

It is reported the surgeon alleges that several patients experienced iatrogenic fractures of the humeral neck during insertion of the humeral nail.

• Brand Name: UNKNOWN ZIMMER HUMERAL NAIL
• Type of Device: TRAUMA PROSTHESIS
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5563901
• MDR Text Key: 42265822
• Report Number: 1822565-2016-00991
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2016
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other