MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, LEFT, 9X160MM; AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL

Model Number	N/A
Medical Device Problem Codes	Mechanical Problem (1384); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: proximal humerus nail cap, 0mm; catalog#: 47-2488-010-00; lot#: 3076770.Cortical bone screw, ã¿ 4x24mm; catalog#: 47-2486-124-40; lot#: 3068968.Cortical bone screw, ã¿ 4x26mm; catalog#: 47-2486-126-40; lot#: 3039382.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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).The following reports are associated with this event: 0009613350-2022-00048; 0009613350-2022-00049; 0009613350-2022-00050.
Event or Problem Description
It was reported that a ann blunt screw backed out.The surgeon keep an eye on the patient condition as well as no revision will be planned so far.
Event or Problem Description
It was reported that a ann blunt screw backed out.The surgeon keep an eye on the patient condition as well as no revision will be planned so far.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of initial medwatch.New information received: the name of the surgeon : (b)(6).Investigation of this incident is currently ongoing, a follow up report will be submitted when additional information becomes available.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2022-00047.
Event or Problem Description
Investigation results are now available.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
The device will not be returned for analysis, because it remains implanted.Investigation of the reported event has been completed.Event occurred in japan.Zimmer's reference: (b)(4).Investigation and conclusion: 1.Event description: it was reported that the patient underwent primary operation with ann nail on (b)(6) 2021.After 10 days, the surgeon found the second most proximal screw backed out from the proper position.The surgeon is keeping an eye on the patient condition and no revision has been planned so far.The corelock mechanism was utilized.Harm: s2 - instability, minor hazardous situation: implant deteriorates, breaks or loses function postoperatively.2.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.No medical data relevant to the case has been received.3.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.4.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.Surgical technique sap: the surgical technique explains that the locking of the corelock is done using the corelock driver with torque limiting handle: turn slowly clockwise to tighten and engage the corelock mechanism until a click is felt from the torque limiting handle.5.Conclusion: it was reported that the patient underwent primary operation with ann nail on (b)(6) 2021.After 10 days, the surgeon found the second most proximal screw backed out from the proper position.The surgeon is keeping an eye on the patient condition and no revision has been planned so far.The corelock mechanism was utilized.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).Neither x-rays, operative notes, office visit notes, nor devices or photos of the devices were received; therefore, the condition of the components 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 it could be assumed that possible contributing factors to the migration of the screw might be multifactorial related to either patient condition and behavior, implantation procedure or design features.If and to what extent any of these aspects may have influenced the backing out of the screw remains unknown.In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the migration of the screw.Further investigation has been initiated in order to determine the need of potential corrective and / or preventive actions.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The following reports are associated with this event: 0009613350-2022-00047-2, 0009613350-2022-00048-2, 0009613350-2022-00049-2, and 0009613350-2022-00050-2.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PROXIMAL HUMERUS, LEFT, 9X160MM
• Common Device Name: AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL
• 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: 13384826
• Report Number: 0009613350-2022-00047
• Device Sequence Number: 4857940
• Product Code: HSB
• UDI-Device Identifier: 00889024505810
• UDI-Public: 00889024505810
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47-2496-161-09
• Device Lot Number: 3049723
• Was Device Available for Evaluation?: No
• 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: 01/05/2022
• Supplement Date Received by Manufacturer: 02/01/2022; 03/15/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 03/02/2022; 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2020
• 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
• Patient Sex: Unknown