MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, DF DRILL BIT, 4.3, LENGTH 300 MM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer did not receive x-rays for review.Other source documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.Additional information has been requested and is currently not available.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.(b)(4).
Event or Problem Description
The ncb drill bit fractured during the surgery.Surgery was completed with another device.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Event: drill bit fractured during the surgery on (b)(6) 2020 when the surgeon used a 4.3 mm drill bit to secure the ncb pp distal femur plate proximally.Surgeon inferred that the drill fracture was not related to device fatigue.Fractured drill bit remained in the femur as the surgeon was unwilling to retrieve.No relevant medical data has been received.No further due diligence required as all required information to support the conclusion is available or was already requested.Visual examination: no product was returned; therefore, visual and dimensional evaluation could not be performed.It is possible that the instrument was broken due to overload.The bone condition of the patient is also unknown.It can be the case that the patient has hard bone.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 product is intended for treatment.The investigation results did not identify a non-conformance or a complaint out of box (coob).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).
Event or Problem Description
No change to previously reported event.

• Brand Name: NCB, DF DRILL BIT, 4.3, LENGTH 300 MM
• Common Device Name: NCB, DF DRILL BIT, 4.3, LENGTH 300 MM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10355537
• Report Number: 0009613350-2020-00357
• Device Sequence Number: 2329716
• Product Code: JWH
• UDI-Device Identifier: 00889024289277
• UDI-Public: 00889024289277
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 02.00024.003
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 10/09/2020
• 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