MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, CORTICAL SCREW, 5.0 MM, 18 MM; NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/28/2016

Event Type  Injury  

Manufacturer Narrative

The manufacturer did receive per for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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 on the unknown side and experienced radial nerve palsy.

Event Description

Patient was implanted on the unknown side and experienced radial nerve palsy.

Manufacturer Narrative

Additional information which was received on jan 13, 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer did not receive any documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

Investigation has been completed.

Manufacturer Narrative

Investigation results were made available.Additional: h2, h6.Correction: b4, b5, g3, g6, h10.Event description: it was reported that patient experiences radial nerve palsy.The ncb plate remains implanted.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: no product was returned as it remains implanted; therefore, visual and dimensional evaluation could not be performed.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.- instruction for use (ifu): the applicable instruction for use was reviewed.However, since no surgical report was received it was not possible to compare and evaluate possible contributing factors.Conclusion: it was reported that patient experiences radial nerve palsy.The ncb plate remains implanted.No x-rays to evaluate the implant position and other possible contributing factors were received.Patient factors that may have contributed to the reported event and relevant medical history are unknown.Due to the lack of information it was not possible to investigation if and to what extend the implanted product may have contributed to the reported event.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).The following reports are associated with this event: 0009613350-2020-00613-2.0009613350-2021-00033-1.0009613350-2021-00031-1.0009613350-2021-00029-1.0009613350-2021-00034-1.0009613350-2021-00032-1.0009613350-2021-00030-1.0009613350-2020-00614-1.

• Brand Name: NCB, CORTICAL SCREW, 5.0 MM, 18 MM
• Type of Device: NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11071227
• MDR Text Key: 223590273
• Report Number: 0009613350-2020-00612
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K061211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 02.02150.018
• Device Lot Number: 2610510
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 58