MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, CANCELLOUS SCREW,¸ 5.0 MM, 32 MM, 65 MM; NCB PLATING SYSTEM

Model Number	N/A
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device: ncb, locking cap; catalog# 0203150300; lot#4503697110.Ncb, cancellous screw, 5.0 mm, 32 mm, 75 mm; catalog#: 0203152075; lot#: 4501992942.Ncb, cancellous screw, 5.0 mm, 32 mm, 75 mm; catalog#: 0203152075; lot#: 4503243563.Ncb, screw¸ 5.0, 30 mm; catalog#0203150030; lot# unknown.Ncb, cancellous screw, 5.0 mm, 32 mm, 65 mm; catalog#: 0203152065; lot#:4501992942.Ncb, cancellous screw, 5.0 mm, 32 mm, 60 mm; catalog#: 0203152060; lot#:4501787166.Ncb, femur plate, right, 9 holes, 246 mm; catalog# 0203260009; lot#2975382.Therapy date: (b)(6) 2021.The manufacturer did not receive x-rays for review.Other documents were received and will be reviewed as part of ongoing investigation.Lot numbers were received and the device history records were reviewed and found to be conforming.The process of gaining necessary information is still ongoing.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 right side and underwent revision due to device migration.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that the patient was implanted with ncb distal femur plate on (b)(6) 2020 and underwent a revision surgery on (b)(6) 2021 since the screws had separated from the plate proximally (migrated).Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: visual examination: the visual examination shows scratches on the surface of the plate.On three distal screw holes, there are signs of wear.One the 5 cancellous screws, there are no signs of damage.On the 3 self-tapping screws, there are signs of wear on each screw head.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Ncr(s): no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that the patient was implanted with ncb distal femur plate on (b)(6) 2020 and underwent a revision surgery on (b)(6), 2021 since the screws had separated from the plate proximally (migrated).Based on the investigation the reported event cannot be confirmed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).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).
Event or Problem Description
No change to previously reported event.

• Brand Name: NCB, CANCELLOUS SCREW,¸ 5.0 MM, 32 MM, 65 MM
• Common Device Name: NCB PLATING SYSTEM
• 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: 12538913
• Report Number: 0009613350-2021-00495
• Device Sequence Number: 19891576
• Product Code: HRS
• UDI-Device Identifier: 00889024296008
• UDI-Public: 00889024296008
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted 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): 11/12/2021

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 Model Number: N/A
• Device Catalogue Number: 02.03152.065
• Device Lot Number: 4501798707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• 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: 09/14/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown