MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH AFFIXUS NAIL TRAUMA IMPL

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

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.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 biomets reference number of this file is (b)(4).

Event Description

Patient was implanted on an unknown side and implant was fractured on (b)(6) 2021.Subsequently, underwent revision surgery.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Additional: h2, h6 correction: b4, g3, g6, h1.Event description: it was reported that the patient was implanted with an affixus nail in (b)(6) 2020 and implant was fractured in (b)(6) 2021.Subsequently, the patient underwent revision surgery on (b)(6) 2021.During surgery fractured implant was removed and external fixation put in place.Review of received data: due diligence: further due diligence to support the conclusion was completed and documented.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: document review could not be performed due to unknown product identification.Device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed as only the complained product is known.Conclusion: it was reported that the patient was implanted with an affixus nail in (b)(6) 2020 and implant was fractured in (b)(6) 2021.Subsequently, the patient underwent revision surgery on (b)(6) 2021.During surgery fractured implant was removed and external fixation put in place.Neither x-rays, operative notes, office visit notes, nor device or photos of the device were received; therefore the condition of the component is unknown.Patient factors that may have affected the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.Based on the investigation the reported event cannot be confirmed.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or 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.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that the initial report was forwarded in error and should be voided.This event will be further reported under correct mfr# : 0001825034 -2022 -00851.

Event Description

Upon receipt of additional information, it has been determined that the initial report was forwarded in error and should be voided.This event will be further reported under correct mfr# 0001825034-2022-00851.

• Brand Name: AFFIXUS NAIL TRAUMA IMPL
• Type of Device: AFFIXUS NAIL TRAUMA IMPL
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12040597
• MDR Text Key: 257446363
• Report Number: 0009613350-2021-00301
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2022
• 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
• Patient Sex: Female