MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, DF TORQUE SCREWDRIVER, 6 NM, 280 MM; NCB PLATING SYSTEM DISTAL FEMUR AND PROXIMAL TIBIA

Model Number N/A

Device Problems Use of Device Problem (1670); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer received photographs which will be reviewed as part of ongoing investigation.The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.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 Description

It was reported that a screw driver is stripped and loses bite.

Event Description

Investigation has been completed.

Manufacturer Narrative

Investigation results were made available.Event description: it was reported that the hex part of the screwdriver was stripped.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Visual examination: the instrument shows signs of usage.The hexagonal tip is slightly deformed.The device was manufactured in 2015.It can be assumed that the instrument was in use for several times.The product is intended for treatment.The investigation results did not identify a non-conformance or a complaint out of box (coob).It is possible that the instrument was not used correctly.The whole hexagonal part has to be inserted in the screw hole to avoid any damages on this area.However, based on the investigation, we were not able to identify a specific root cause.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, DF TORQUE SCREWDRIVER, 6 NM, 280 MM
• Type of Device: 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: 12959509
• MDR Text Key: 281906680
• Report Number: 0009613350-2021-00656
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00889024289338
• UDI-Public: 00889024289338
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 02.00024.021
• Device Lot Number: 15160127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 01/19/2022
• Supplement Dates FDA Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/02/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1