MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZNN CMN LAG SCREW, 10.5 MM, 95 MM, INCLUDING SET SCREW; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	03/25/2021
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 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
Patient was implanted on the left side and during the cephalic screw removal the fins of the screw fractured.Since the screw could not be removed using the screwdriver, the surgeon had to impact the product with the risk of fracture to the acetabulum cup and femoral neck of the patient.
Event or Problem Description
No event update.Investigation results are now available.
Additional Manufacturer Narrative
Investigation results were made available.Additional: d9, h2, h6.Correction: b4, b5, g3, g6, h3, h10.Review of event description: the event occurred during the nail removal from the left femur.During the cephalic screw removal the fins of the screw got fractured.Since the screw could not be removed using the screwdriver, the surgeon had to impact the product with risk of fracture for the patient (acetabulum cup and femoral neck).Visual examination: the lag screw was returned for investigation.The visual examination shows that the lag screw flanks were cracked and deformed but not completely fractured.In addition, there are circular marks visible on shaft area of the lag screw.This can be caused during the implantation or while trying to remove the lag screw.Surgical technique: the correct lag screw placement/removal is described in the zimmer natural nail system ¿ cephalomedullary standard surgical technique.The product is intended for treatment.The investigation results did not identify a non-conformance or a complaint out of box (coob).It is assumed that the flanks were cracked due to an overload.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 flanks which lead to a fracture/crack of this section.- 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, we were not able to identify a specific root cause for this issue.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).

• Brand Name: ZNN CMN LAG SCREW, 10.5 MM, 95 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: 11699395
• Report Number: 0009613350-2021-00178
• Device Sequence Number: 11633249
• Product Code: HSB
• UDI-Device Identifier: 00889024298446
• UDI-Public: 00889024298446
• 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: 2019
• Device Explanted Year: 2021
• 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): 08/12/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-095-10
• Device Lot Number: 2995906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 08/12/2021
• 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; Required Intervention
• Patient Age: 50 YR