MAUDE Adverse Event Report: ZIMMER GMBH ZNN CMN NAIL 11.5MMX21.5CM 130R; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Catalog Number 47-2493-212-11

Device Problem Break (1069)

Patient Problems Pain (1994); Swelling (2091)

Event Date 01/22/2016

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive the device for investigation.No surgical report or x-rays were provided for review.Medical notes and one picture were received and will be reviewed within the investigation.Where lot number was received for the device, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted.(b)(4).

Event Description

It was reported that the patient was implanted a znn cmn nail 11.5mmx21.5cm 130r on the right side on (b)(6) 2015.It was reported that the patient was revised on (b)(6) 2016 due to nail breakage.In addition there was a fracture of the femur, pain and swelling.Note: two different nails were reported for the same event (see other case with mfr 9613350-2016-00496).Within the available information, it is not mentioned which of these nails is actually related to the breakage.Two reports were therefore filed.

Manufacturer Narrative

Trend analysis: no trend was identified.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Review of event description: it was reported that the patient was revised due to nail breakage which happened while she was standing and twisting.In addition there was fracture of the femur, pain and swelling.Review of received data: pictures of the broken nail were received.The device is broken at the lag screw hole.No surgical report or x-rays were received.Radiology report created on (b)(6) 2016 indicates that there is a subtrochanteric fracture seen which has fractured the long metallic rod extending down the proximal shaft of the femur.Varus deformity of distal fracture segment is also visible.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Root cause analysis: breakage of implant due to inadequate design of mating components: not possible: a systemic issue with design and/or material properties would have been detected within the complaint summary; breakage of implant due to lack of adequate fatigue strength: possible, breakage surface could not be analyzed, cannot be excluded; breakage of implant due to lack of adequate fatigue strength due to anodization: possible, breakage surface could not be analyzed, cannot be excluded; breakage of implant due to incorrect distal nail design for short nails (flexible nail end): not possible: a systemic issue with design and/or material properties would have been detected within the complaint summary; breakage of implant due to general corrosion (crevice, pitting, galvanic): possible, no surgical report was received, therefore cannot be excluded; breakage of implant due to the implant therapy is not performed as indicated: possible, no information regarding that issue wa sreceived, therefore cannot be excluded; breakage of implant due to wrong interpretation of x-rays templates for dimensions lead to malreduction of the fracture: possible, no x-rays provided right after primary implantation, therefore cannot be excluded; breakage of implant due to users select wrong nail diameter,length and/or determine wrong ccd angle: possible, neither post operative x-rays and surgical reports were returned for investigation.Therefore cannot be excluded; breakage of implant due to users choose wrong targeting guide/wrong cephalomedullary nail leading to drilling of nail: possible, product not returned and could not have been analyzed, therefore cannot be excluded; breakage of implant due to wrong/incomplete information about limitation and postoperative restriction: possible, no information regarding that issue was received, therefore cannot be excluded.Conclusion summary: neither surgical report nor x-rays images and product were received.Therefore it is not possible to state any possible root causes.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer's reference number of this file is (b)(4).

Manufacturer Narrative

Follow-up information received on july 11, 2016.It has now been reported that the patient was implanted a znn cmn nail 10mmx21.5cm 130r (ref#: 47-2493-212-10), not a znn cmn nail 11.5mmx21.5cm 130r (ref#: 47-2493-212-11).The case about znn cmn nail 10mmx21.5cm 130r has already been reported under (b)(4) - mfr report number 9613350-2016-00496-2.Therefore, zimmer (b)(4) considers this case as closed.Zimmer's reference number of this file is (b)(4).

Event Description

Follow up information received on july 11, 2016.It has now been reported that the patient was implanted a znn cmn nail 10mmx21.5cm 130r, not a znn cmn nail 11.5mmx21.5cm 130r.The case about znn cmn nail 10mmx21.5cm 130r has already been reported under (b)(4) - mfr report number 9613350-2016-00496-2.Please rectify your records.

• Brand Name: ZNN CMN NAIL 11.5MMX21.5CM 130R
• Type of Device: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER GMBH; sulzerallee 8; winterthur, 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 5742676131
• MDR Report Key: 5488872
• MDR Text Key: 39977478
• Report Number: 9613350-2016-00497
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2016

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: Lay User/Patient
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 47-2493-212-11
• Device Lot Number: 2756723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2016
• Initial Date FDA Received: 03/09/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/07/2016; 08/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 74