MAUDE Adverse Event Report: ZIMMER INC ZNN FEMORAL NAIL; HSB

Catalog Number 47249238013

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported it was very hard to remove the nail from the patient's bone.

Manufacturer Narrative

Review of the returned device noted damage on the upper end of the screw and several scratches on the cylindrical part of the screw.The returned nail appears free of damage, except a small scratch in the middle.The product was measured against the print specifications at several dimensions and all measurements taken were in specification.The device history records were reviewed, indicating products met specifications at the time of manufacture.The nail is used for treatment.The nail was in-vivo for over a year; it was indicated that the patient bone was cured in that time, and is the reason for explantation.The package insert included with this implant states that, "temporary internal fracture fixation devices are designed to stabilize the fracture site during the normal healing process.After healing occurs, these devices serve no functional purpose and should be removed." the surgical technique instructs "if bone has grown into any of the screws, nail cap or nail that would inhibit implant removal, use instruments such as rongeurs, dental picks or drills to remove bone in-growth before attempting implant removal.Take care not to damage the implant itself while removing ingrown bone." a definitive root cause for this event cannot be determined with the information provided.

• Brand Name: ZNN FEMORAL NAIL
• Type of Device: HSB
• 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: 5112027
• MDR Text Key: 27095726
• Report Number: 1822565-2015-01982
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Followup
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 47249238013
• Device Lot Number: 61556098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2010
• 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 Age: 20 YR
• Patient Weight: 70