MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, RIGHT, LONG, 7X220MM; AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer did not receive x-rays for review.Other documents were received and will be reviewed as part of ongoing investigation.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 or Problem Description
Patient was implanted on an unknown side and underwent revision surgery due to implant fracture.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additional information was received on jul 14, 2021.The manufacturer received other source 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 in (b)(4).
Event or Problem Description
Patient was implanted on an unknown side and underwent revision surgery due to implant fracture.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Additional: h2, h6.Correction: b4, g3, g6, h10.Event description: it was reported that the patient was implanted with affixus nail on (b)(6) 2021 and underwent revision surgery on (b)(6) 2021 due to implant fracture.Any kind of trauma has not been reported.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: - device purpose: this device is intended for treatment.- product compatibility: the compatibility check could not be performed as only the complained product is known.- dhr review: review of the device history records identified no deviations or anomalies during manufacturing.- raw material certificate: the raw material certificate was reviewed with no anomalies noted.Conclusion: it was reported that the patient was implanted with affixus nail on (b)(6) 2021 and underwent revision surgery on (b)(6) 2021 due to implant fracture.Any kind of trauma has not been reported.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.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: PROXIMAL HUMERUS, RIGHT, LONG, 7X220MM
• Common Device Name: AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 12157902
• Report Number: 0009613350-2021-00337
• Device Sequence Number: 17086014
• Product Code: HSB
• UDI-Device Identifier: 00889024505896
• UDI-Public: 00889024505896
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K200814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 09/22/2021

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: 47-2496-220-07
• Device Lot Number: 2988091
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 07/14/2021; 09/17/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 07/26/2021; 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention