MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZNN, CMN LAG SCREW, 10.5 MM, 105 MM INCLUDING SET SCREW; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical products: cmn femoral nail, ccd 125, left, 11.5 mm, 21.5 cm; catalog#: 47249321111; lot#: 3000494.Therapy date: unknown.The manufacturer received x-rays and other source documents for review.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
During surgery, all the instrumentation had been checked and the angle chosen for the nail was good.Despite this, the screw got stuck in the nail and surgeon was unable to remove it because the fins were broken.Revision surgery is re-scheduled to remove the implant.Surgical delay of one hour.
Additional Manufacturer Narrative
Event description: it was reported that during surgery on (b)(6) 2020, all the instrumentation had been checked and the angle chosen for the nail was good.Despite this, the screw got stuck in the nail and surgeon was unable to remove it because the cams were broken.Revision surgery is re-scheduled to remove the implant.Review of received data: x-rays: one intra-operative x-ray picture was received.The x-ray was reviewed by a healthcare professional.The quality of the received x-ray is very poor so a clear statement about the lag screw fracture cannot be done.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Raw material certificate: the raw material certificate was reviewed with no anomalies noted.Surgical technique: the correct lag screw placement is described in the zimmer natural nail system ¿ cephalomedullary standard surgical technique.Conclusion: it was reported that during surgery on (b)(6) 2020, all the instrumentation had been checked and the angle chosen for the nail was good.Despite this, the screw got stuck in the nail and surgeon was unable to remove it because the cams were broken.Revision surgery is re-scheduled to remove the implant.The lag screw was not returned for investigation.The correct lag screw removal is described in the zimmer natural nail system ¿ cephalomedullary standard surgical technique.If the lag screw cams were sheared off, it can be assumed that this occurred due to an overload on the cams.Possible causes for the overload could be: unfavorable placement between the instrument and the implant so their contact surface is too small, too high forces will be transmitted on the cams which lead to a fracture of this section.The correct lag screw placement is described in the zimmer natural nail system ¿ cephalomedullary standard surgical technique.Pathogenic bone diseases (e.G.Bone tumor) which can affect mechanical properties of the bone (harder/ denser bone substance).This could also lead to higher forces of these sections.However, based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The investigation did not identify a nonconformance or a complaint out of box (coob).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 or Problem Description
Investigation result is available now.

• Brand Name: ZNN, CMN LAG SCREW, 10.5 MM, 105 MM INCLUDING SET SCREW
• 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: 9966393
• Report Number: 0009613350-2020-00193
• Device Sequence Number: 3835897
• Product Code: HSB
• UDI-Device Identifier: 00889024298460
• UDI-Public: 00889024298460
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2020

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 Expiration Date: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-105-10
• Device Lot Number: 3008697
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 12/29/2020
• 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