MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB®, DRILL BIT, 3 MM, 195 MM; NCB PLATING SYSTEM DISTAL FEMUR AND PROXIMAL TIBIA

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.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).
Event or Problem Description
It was reported that during femur periprosthetic plate surgery they were drilling to make a hole to put one of the screws and the tip of the drill bit broke.No harm to patient.
Event or Problem Description
No change to previously reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Product evaluation: visual examination: the drill was returned for investigation.A visual examination was performed.The drill seems to be damaged.The instrument was fractured in the cutting area.The broken piece was retrieved from the patient but not returned for investigation.Review of received pictures: the device was also received for visual examination.Review of the device history records identified no deviations or anomalies during manufacturing.No further due diligence required as all required information to support the conclusion is available or was already requested.Device is used for treatment.Insufficient information provided.Unable to perform a compatibility check.Review of complaint history identified additional similar complaint for the reported item and no additional complaints for the reported part and lot combination related to the event.Medical records were not provided.The investigation did not identify a nonconformance or a complaint out of box (coob).A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: NCB®, DRILL BIT, 3 MM, 195 MM
• Common Device Name: NCB PLATING SYSTEM DISTAL FEMUR AND PROXIMAL TIBIA
• 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: 13759489
• Report Number: 0009613350-2022-00153
• Device Sequence Number: 5749848
• Product Code: HRS
• UDI-Device Identifier: 00889024289260
• UDI-Public: 00889024289260
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K192217
• 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): 05/24/2022

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 Model Number: N/A
• Device Catalogue Number: 02.00024.002
• Device Lot Number: 4504184603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/14/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown