MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, CANCELLOUS SCREW, 5.0 MM, 32 MM, 60 MM; NCB PLATING SYSTEM

Model Number N/A

Device Problems Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 08/19/2021

Event Type  Injury  

Manufacturer Narrative

Medical products: ncb, cancellous screw, 5.0 mm, 32 mm, 75 mm; catalog#: 02.03152.075; lot#: unknown.Ncb, screw, 5.0, 30 mm; catalog#: 02.03150.030; lot#: unknown.Ncb, cancellous screw, 5.0 mm, 32 mm, 65 mm; catalog#: 02.03152.065; lot#: unknown.Ncb, femur plate, right, 9 holes, 246 mm; catalog#: 02.03260.009; lot#: 2975382.Ncb, locking cap; catalog#: 02.03150.300; lot#: unknown.Ncb, locking cap; catalog#: 02.03150.300; lot#: unknown.Ncb, locking cap; catalog#: 02.03150.300; lot#: unknown.Ncb, locking cap; catalog#: 02.03150.300; lot#: unknown.Ncb, locking cap; catalog#: 02.03150.300; lot#: unknown.Therapy date: (b)(6) 2021.The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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

Patient was implanted with an ncb distal femur plate on the right side and underwent a revision surgery since the screws had separated from the plate proximally(migrated).

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 Description

No change to previously reported event.

• Brand Name: NCB, CANCELLOUS SCREW, 5.0 MM, 32 MM, 60 MM
• Type of Device: 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: 12407308
• MDR Text Key: 269373862
• Report Number: 0009613350-2021-00443
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00889024295995
• UDI-Public: 00889024295995
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042695
• 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: 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
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 02.03152.060
• Device Lot Number: UNKNOWN
• 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
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 11/05/2021
• Supplement Dates FDA Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention