MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 125, RIGHT, 9.3 MM, 18 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT

Model Number	N/A
Medical Device Problem Codes	Fitting Problem (2183); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the device(s), 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 / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.(b)(4).
Event or Problem Description
During surgery, when trying to connect the nail to the guide with the help of the bolt, the bolt would not turn and got stuck.A backup nail could be connected without any problem.There was no surgical delay.
Additional Manufacturer Narrative
Additional information which was received on nov 20, 2020.Medical products: znn, cmn targeting guide, asia; catalog #: 00249000900; lot#: 12721376.Znn, cmn connecting bolt, asia; catalog #: 00249000304; lot#: 12765809.Therapy date: unknown.The manufacturer received other source documents (photos) for review.Should additional information become available and / or the device(s) be returned for evaluation 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 or Problem Description
During surgery, when trying to connect the nail to the guide with the help of the bolt, the bolt would not turn and got stuck.A backup nail could be connected without any problem.Also, the nail could not be connected to other devices.There was no surgical delay.
Event or Problem Description
During surgery, when trying to connect the nail to the guide with the help of the bolt, the bolt would not turn and got stuck.A backup nail could be connected without any problem.Also, the nail could not be connected to other devices.There was no surgical delay.
Additional Manufacturer Narrative
Additional information which was received on mar 18, 2021.D10: medical products: cmn femoral nail, ccd 125, right, 10 mm, 18 cm; item#: 47249318010; lot#: 302583.The manufacturer received other source documents for review.Should any additional information become available or 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).
Additional Manufacturer Narrative
Event description: it was reported that during surgery on the (b)(6) 2020, the znn cmn nail couldn't be properly assembled with the connection bolt.The connection bolt didn't turn and was stuck.Another znn cmn nail was used to complete the surgery.Review of received data: - no medical data relevant to the case has been received.- due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.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.- functional test: a functional test was performed on the returned znn cmn nail with the connection bolt.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.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 6th november 2020, the znn cmn nail couldn't be properly assembled with the connection bolt.The connection bolt didn't turn and was stuck.Another znn cmn nail was used to complete the surgery.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 an issue evaluation.Based on the investigation the report event can be confirmed.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
No change to previously reported event.

• Brand Name: CMN FEMORAL NAIL, CCD 125, RIGHT, 9.3 MM, 18 CM
• Common Device Name: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10868567
• Report Number: 0009613350-2020-00542
• Device Sequence Number: 11398628
• Product Code: HSB
• UDI-Device Identifier: 00889024298637
• UDI-Public: 00889024298637
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120715
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/03/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-180-09
• Device Lot Number: 3031716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 11/20/2020; 03/18/2021; 04/30/2021
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 12/01/2020; 03/26/2021; 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REFER H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other