MAUDE Adverse Event Report: ZIMMESWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, RIGHT, 7X160MM; AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL

Model Number	N/A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: cortical bone screw, 4x28mm; catalog#: 47-2486-128-40; lot#: 3073722.Cortical bone screw, 4x28mm; catalog#: 47-2486-128-40; lot#: 3076755.Blunt tip screw, 4x58mm; catalog#: 47-2486-058-40; lot#: 3054254.Proximal humerus nail cap, 10.5x2.5mm; catalog#: 47-2488-010-02; lot#: 3068978.The manufacturer received x-rays and 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: 0009613350-2022-00101; 0009613350-2022-00102; 0009613350-2022-00103.
Event or Problem Description
It was reported that operation was performed with ann nail system.After 4 weeks from the initial, surgeon found three proximal screws were backed out from the proper position.The surgeon keep an eye on the patient condition as well as no revision will be planned so far.
Additional Manufacturer Narrative
Concomitant medical products: cortical bone screw, 4x28mm; catalog#: 47-2486-128-40; lot#: 3073722.Cortical bone screw, 4x28mm; catalog#: 47-2486-128-40; lot#: 3076755.Blunt tip screw, 4x58mm; catalog#: 47-2486-058-40; lot#: 3054254.Proximal humerus nail cap, 10.5x2.5mm; catalog#: 47-2488-010-02; lot#: 3068978.The manufacturer received x-rays and 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: 0009613350-2022-00101; 0009613350-2022-00102; 0009613350-2022-00103.
Event or Problem Description
It was reported that operation was performed with ann nail system.After 4 weeks from the initial, surgeon found three proximal screws were backed out from the proper position.The surgeon keep an eye on the patient condition as well as no revision will be planned so far.
Event or Problem Description
Investigation has been completed.
Additional Manufacturer Narrative
Event description: it was reported that operation was performed with ann nail on (b)(6), 2021.After 4 weeks from the initial, surgeon found three proximal screws were backed out from the proper position.The surgeon keep an eye on the patient condition as well as no revision will be planned so far.No patient outcome.Review of received data: - no medical reports available - due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.- x-rays: some x-ray pictures were avaialble for investigation.The x-ray review shows that the proximal screws were backed out.Therefore, the reported event can be confirmed.Product evaluation: - no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: - device purpose: all involved devices are intended for treatment.- product compatibility: the product combination was approved by zimmer biomet.- surgical technique: the applicable 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.- dhr review: the quality records show that all specified characteristics have met the specifications valid at the time of production with no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that operation was performed with ann nail on (b)(6), 2021.After 4 weeks from the initial, surgeon found three proximal screws were backed out from the proper position.The surgeon keep an eye on the patient condition as well as no revision will be planned so far.No patient outcome.The quality records show that all specified characteristics have met the specifications valid at the time of production.The received x-rays confirm the reported event, namely that the most proximal screw has migrated.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, behaviour or implantation procedure.If and to what extent any of these aspects may have influenced the migration of the screw remains unknown.An additional deeper investigation was performed which identified the design limitation of the corelock mechanism as a potential contributing factor.However, as further biomechanical testing was carried out and the performance is in an acceptable range in comparison with legally marketed similar devices, no design changes were conducted.In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the migration of the screw.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: 0009613350-2022-00101-1.0009613350-2022-00102-1.0009613350-2022-00103-1.

• Brand Name: PROXIMAL HUMERUS, RIGHT, 7X160MM
• Common Device Name: AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL
• Manufacturer (Section D): ZIMMESWITZERLAND 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: 13583785
• Report Number: 0009613350-2022-00100
• Device Sequence Number: 4368586
• Product Code: HSB
• UDI-Device Identifier: 00889024505773
• UDI-Public: 00889024505773
• 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): 05/09/2022

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: 47-2496-160-07
• Device Lot Number: 3031219
• 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: 01/28/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male