MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, RIGHT, 11X160MM; AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

Model Number	N/A
Medical Device Problem Codes	Mechanical Problem (1384); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical product: cortical bone screw, 4x28mm, catalog#: 47-2486-128-40; lot#: 3048195; cortical bone screw, 4x28mm, catalog#: 47-2486-128-40 ; lot#: 3054467; proximal humerus nail cap, 0mm, catalog#: 47-2488-010-00 ; lot#: 3068927.X-rays and photographs were received and will be reviewed as part of ongoing 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: 0009613350-2021-00594; 0009613350-2021-00592.0009613350-2021-00593.Remains implanted.
Event or Problem Description
It was reported that: surgeon found 2nd screw of the proximal screws was backed out from the proper position.
Event or Problem Description
Investigation results are now available.
Additional Manufacturer Narrative
Investigation results were made available.Additional: d6, h2, h6 correction: b4, b5, g3, g6, h10.1.Event description: it was reported that the patient received an implant in the right humerus on (b)(6) 2021 and after two weeks from the initial surgery, the surgeon discovered that the second most proximal screw had gradually backed out from the proper position.No revision surgery has taken place.The patient is being monitored.The corelock mechanism has been reported as being engaged with the torque screwdriver after the interlocking screws were placed.Harm: s2 - instability, minor hazardous situation: loss of fixation or non-integration of an implant.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.- x-rays: a total of seven undated but labeled x-ray images for the right humerus were provided, consisting of: two ap x-rays prior to implantation on (b)(6) 2021, two ap x-rays immediately post-implantation, two ap x-rays one week post-implantation and one ap x-ray two weeks post-implantation.Contrary to the event description, where it is stated that a backing out of the second most proximal screw was observed two weeks post-implantation, indication of a backing out of the second most proximal screw can be observed in the provided one week post-operative images when comparing with the images taking directly post-implantation.3.Product evaluation: - no product was returned; therefore, visual and dimensional evaluation could not be performed.The devices remain implanted.4.Review of product documentation: - device purpose: this 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.- surgical technique sap: the surgical technique 197-glbl-en 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 received an implant in the right humerus on (b)(6) 2021 and after two weeks from the initial surgery, the surgeon discovered that the second most proximal screw had gradually backed out from the proper position.No revision surgery has taken place.The patient is being monitored.The corelock mechanism has been reported as being engaged with the torque screwdriver after the interlocking screws were placed.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).A total of seven x-rays from prior to the implantation to two weeks post-implantation were provided.Contrary to the reported event description, where it is stated that a backing out of the second most proximal screw was observed two weeks post-implantation, indication of a backing out of the second most proximal screw can be observed in the provided one week post-operative images when comparing with the images taking directly post-implantation.The reported event of screw migration can therefore be confirmed.No further medical documents or any patient information were received.Based on the investigation it could be assumed that further possible contributing factors to the migration of the screw might be multifactorial related to either patient condition, 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.Further investigation has been initiated in order to determine the need of potential corrective and / or preventive actions.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; 0009613350-2021-00594-1; 0009613350-2021-00593-1; 0009613350-2021-00592-1.

• Brand Name: PROXIMAL HUMERUS, RIGHT, 11X160MM
• 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
• 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: 12842756
• Report Number: 0009613350-2021-00595
• Device Sequence Number: 19921607
• Product Code: HSB
• UDI-Device Identifier: 00889024505797
• UDI-Public: 00889024505797
• 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
• Report Date (Section B): 12/20/2021

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: 47-2496-160-11
• Device Lot Number: 3007826
• 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: 10/21/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown