MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 125, RIGHT, 11.5 MM, 21.5 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number N/A

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did receive pictures of the znn cmn nail for review.The manufacturer did not receive the device for investigation.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.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on the unknown side and during surgery the bolt didn't turn and got stuck, another nail (13 mm) was used to complete the procedure.0-15 min delay was noted due to prepare a back-up implant.

Manufacturer Narrative

Investigation results were made available.Event description: it was reported that during surgery on the 21st december 2020, the znn cmn femoral nail couldn't be properly assembled with the connection bolt.The connection bolt didn't turn and was stuck.Another znn cmn femoral nail was used to complete the surgery.There was a surgical delay of up to 15 minutes to prepare a backup nail.Review of received data: - no medical data relevant to the case has been received.Product evaluation: - visual examination: the visual examination shows a shiny surface present at the start of the thread along with signs of wear, confirming the reported attempts made of assembling the connection bolt to the znn cmn nail.(refer to diligence log dl1589068 for the attached pictures and for the rationale of why the attached pictures are used for the visual examination.) - functional test: a functional test was performed on the returned znn cmn nail with the connection bolt ref.00-2490-003-04.The results of the functional test was negative.The connection bolt couldn't be assembled to the znn cmn nail.- deeper manufacturing investigation: a deeper manufacturing investigation was performed and a cad simulation was generated.There is an offset in the axis y4+ due to the milling tool not being used concentrically to the turning diameter.(refer to diligence log (b)(4) and the attached.Pptx file on slide 5).Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the product combination of the connection bolt and znn cmn nail was approved by zimmer biomet.Conclusion: it was reported that during surgery on the 21st december 2020, the znn cmn femoral nail couldn't be properly assembled with the connection bolt.The connection bolt didn't turn and was stuck.Another znn cmn femoral nail was used to complete the surgery.There was a surgical delay of up to 15 minutes to prepare a backup nail.The investigation did identify a nonconformance or a complaint out of box (coob).The visual examination shows a shiny surface present at the start of the thread along with signs of wear, confirming the reported attempts made of assembling the connection bolt to the znn cmn nail.The functional test done with the connection bolt produced a negative result.The connection bolt could not be assembled to the znn cmn nail.A deeper manufacturing investigation was performed and a cad simulation was generated.It was discovered that there is an offset in the axis y4+ due to the milling tool not being used concentrically to the turning diameter.This offset in concentricity between the m11 thread and the ø10.185 core-diameter prevents the connection bolt being assembled with the znn cmn nail.Based on the given information and the results of the investigation, we identified the root cause to be a manufacturing issue.Further actions were initiated and are covered in issue evaluation (b)(4).Based on the investigation the report event can be confirmed.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

Investigation results are now available.

• Brand Name: CMN FEMORAL NAIL, CCD 125, RIGHT, 11.5 MM, 21.5 CM
• Type of Device: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11176891
• MDR Text Key: 228235621
• Report Number: 0009613350-2021-00014
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024298842
• UDI-Public: 00889024298842
• Combination Product (y/n): N
• PMA/PMN Number: K091566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-210-11
• Device Lot Number: 3025842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization