MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 130 °, RIGHT, 13 MM, 42 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number N/A

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Packaging Compromised (2916); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not yet receive the device for investigation, however it is mentioned that the device will be returned for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A medical device notification which is referenced was sent on (b)(6) 2015 to the customers who may have received one or more of the affected products.The customers were advised to locate affected products, inspect for potential damages, quarantine damaged products and contact a zimmer (b)(4) representative for return of the damaged products via complaint.The packaging in the case at hand was reported as a response to the notification letter.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.(b)(4).

Event Description

It was reported that cmn femoral nail, ccd 130 °, right, 13 mm, 42 cm is returned as a response to the notification letter.

Manufacturer Narrative

Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event summary: it was reported that zmm cmn nails are returned according to medical device notification regarding packaging issue [damage to the carton box and/or to the outer tray].Devices analysis: the packaging of ten affected znn nails were returned for investigation.The visual examination shows that the carton box is damaged at the corners.No further damages could be detected.Inner blister is still intact and the sterile barrier is not affected.Root cause determination using dfmea: infection due to inadequate packaging resulting in leakage of barrier system due to unsterile implant due to packaging failure => not possible: sterile barrier was still intact.Conclusion summary: the reported zmm cmn nails were returned due to a medical device notification from zimmer on september 03, 2015.The dhr of the lot shows no deviation.The visual examination confirms that the carton box is damaged whereas the inner blister is still intact and the sterile barrier is not affected.The results of the investigation shows that it must be a problem with the transportation and/or handling because such damages would be detected within zimmer biomet and would not be released to the market.Such damage could have occurred due to a shock to the packaging e.G.If the package fall down or mishandling in the storage/hospital.The need for further corrective measures is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: CMN FEMORAL NAIL, CCD 130 °, RIGHT, 13 MM, 42 CM
• 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: 6551022
• MDR Text Key: 74601600
• Report Number: 0009613350-2017-00617
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-422-13
• Device Lot Number: 2706638
• Other Device ID Number: 00889024300231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 9613350-08-18-2015-002-C
• Patient Sequence Number: 1