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 Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: surgeon reported lag screw anti-rotation tabs broke off during insertion of lag screw into femoral head.The facility says lag screw inserter is still good.There were no remaining pieces that broke off of the lag screw per surgeon all small pieces were removed and lag screw remained implanted per surgeon.
Additional Manufacturer Narrative
The manufacturer did not receive x-rays, or other source documents for review.The lot number of the device was received.The device history records will be reviewed during investigation.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).Remains implanted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated b4, b5, g3, g6, h2, h6, h10 investigation and conclusion - reported event: it was reported that lag screw anti-rotation tabs broke off during insertion of lag screw into femoral head.No consequences or impact to the patient.- no further due diligence required as all required information to support the conclusion is available or was already requested.- harm: s2 - instability, minor - hazardous situation: user cannot remove existing and well-fixed implants during a medical or surgical intervention.- no medical data (like surgical report or x-rays) relevant to the case has been received.Product evaluation: - no product was returned (still implanted), hence visual and dimensional evaluation could not be performed; therefore, the condition of the parts is unknown.- surgical technique: the correct lag screw placement/removal is described in the zimmer natural nail system ¿ cephalomedullary standard surgical technique.- the quality records show that all specified characteristics (material, dimensions, surface, etc.) for the lag screw have met the specifications valid at the time of production.The raw material certificate of the plate was reviewed with no anomalies noted.- complaint history review: review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination related to the event.- product compatibility: the compatibility check could not be performed as only the complained product is known.- 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 wings were broken/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.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
Investigation results are now available.

• 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
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13334177
• Report Number: 0009613350-2022-00039
• Device Sequence Number: 12040419
• Product Code: HSB
• UDI-Device Identifier: 00889024298446
• UDI-Public: 00889024298446
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2022

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: Health Professional
• Device Expiration Date: 06/11/2026
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-095-10
• Device Lot Number: 3075408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2021
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Sex: Unknown