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
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer receive other source documents 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 or Problem Description
It was reported that during surgery, when the surgeon tried to connect the nail to guide with bolt, the bolt could not turn and was stuck.Surgery was completed with backup nail without any problems.There was a surgical delay of 15 minutes to prepare a back-up implant.
Event or Problem Description
No change to previously reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that during surgery on (b)(6) 2021, 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.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 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.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 (b)(6) 2021, 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 ie-17143.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).

• Brand Name: CMN FEMORAL NAIL, CCD 125, RIGHT, 11.5 MM, 21.5 CM
• Common Device Name: 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: 11560660
• Report Number: 0009613350-2021-00146
• Device Sequence Number: 19885171
• Product Code: HSB
• UDI-Device Identifier: 00889024298842
• UDI-Public: 00889024298842
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091566
• 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
• Report Date (Section B): 05/21/2021

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: 47-2493-210-11
• Device Lot Number: 3025842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 05/21/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization