MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X54MM; AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical product: blunt tip screw, 4x44mm; catalog#: 47-2486-044-40; lot#: 3010654; blunt tip screw, 4x44mm; catalog#: 47-2486-044-40; lot#: 3010655; blunt tip screw, 4x48mm; catalog#: 47-2486-048-40; lot#: 3024724; blunt tip screw, 4x48mm; catalog#: 47-2486-048-40; lot#: 3054391; cortical bone screw, 4x30mm; catalog#: 47-2486-130-40; lot#: 3068972; cortical bone screw, 4x32mm; catalog#: 47-2486-132-40; lot#: 3038400; proximal humerus nail cap, 0mm; catalog#: 47-2488-010-00; lot#: 3068928.The manufacturer received x-rays which will be reviewed as part of ongoing investigation.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: 0009613350-2021-00612.
Event or Problem Description
It was reported that after implantation with ann nail system one of the proximal screw was migrated from the proper position.
Event or Problem Description
Investigation results are now available.
Additional Manufacturer Narrative
Investigation results were made available.Investigation and conclusion: 1.Event description: it was reported that: operation was performed with ann nail on (b)(6) 2021.After 2 weeks from the initial, surgeon found 5th screw of the proximal screw was backed out from the proper position.Patient has a foreign body feeling due to the screw.Surgeon keep an eye on the patient condition as well as no revision will be planned so far.Patient outcome - migration.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.X-rays: there are some x-rays available for investigation.The mentioned screw in the reported event is confirmed to have migrated.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.Raw material certificate: the raw material certificate was reviewed with no anomalies noted.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: operation was performed with ann nail on (b)(6) 2021.After 2 weeks from the initial, surgeon found 5th screw of the proximal screw was backed out from the proper position.Patient has a foreign body feeling due to the screw.Surgeon keep an eye on the patient condition as well as no revision will be planned so far.Patient outcome- migration.The received x-rays confirm the reported event, the 5th screw of the proximal screw has migrated/backed out.It is unknown if the locking of the corelock during the implantation has been performed as specified in the surgical technique using only the corelock driver with torque limiting handle.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.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2021-00612-1.

• Brand Name: BLUNT TIP SCREW, 4X54MM
• 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: 12873598
• Report Number: 0009613350-2021-00611
• Device Sequence Number: 17303024
• Product Code: HSB
• UDI-Device Identifier: 00889024505513
• UDI-Public: 00889024505513
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181827
• 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): 01/14/2022

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 Expiration Date: 08/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 47-2486-054-40
• Device Lot Number: 3039395
• 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: 10/27/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 11/25/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• 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.
• Patient Sex: Male