MAUDE Adverse Event Report: ZIMMER GMBH ZNN CMN NAIL 13MMX30CM 125 R; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number N/A

Device Problems Device Markings/Labelling Problem (2911); Incorrect Device Or Component Shipped (2962)

Patient Problem No Code Available (3191)

Event Date 03/11/2016

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).

Event Description

It was reported that the surgeon wanted to implant a znn cmn nail 11.5mmx30cm 130 l.During implantation it became obvious that the nail was not the one indicated on the label, but a znn cmn nail 13mmx30cm 125 r.An alternative implant was chosen (znn cmn nail 11.5mmx30cm 130 l).

Manufacturer Narrative

It was reported that the surgeon wanted to implant a znn cmn nail 11.5mmx30cm 130 l.During implantation it became obvious that the nail was not the one indicated on the label, but a znn cmn nail 13mmx30cm 125 r.An alternative implant was chosen.No trend is identified.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Both nails were returned for investigation.After receiving the nails and packagings it could be confirmed that the 2 lots were mixed up.A documents analysis showed that the 2 affected lots were processed at the same time in the washing/finish area (with a couple of minute offset), and that their lot identification number are very similar.Therefore the issue could have originated from a handling error.Zimmer (b)(4) initiated a voluntary recall of lot#2840846 and lot#2840845.All affected distributors, hospitals and surgeons have been informed about the recall.The affected products were retrieved and destroyed on may 23, 2016.Zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: ZNN CMN NAIL 13MMX30CM 125 R
• Type of Device: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 5569441
• MDR Text Key: 42386411
• Report Number: 0009613350-2016-00552
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47249330013
• Device Lot Number: 2840846
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2016
• Initial Date FDA Received: 04/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2015
• 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