MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANFACTURING GMBH BLUNT TIP SCREW, 4X48MM; AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

Model Number	N/A
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: medical product: proximal humerus, left, 11x160mm; catalog#: 47-2496-161-11; lot#: 3059714.Blunt tip screw, 4x44mm catalog #:47-2486-044-40; lot #: 3010657.Blunt tip screw, 4x46mm; catalog #: 47-2486-046-40; lot#: 3039376.Blunt tip screw, 4x52mm; catalog#: 47-2486-052-40; lot#: 3054392.Blunt tip screw, 4x54mm; catalog#: 47-2486-054-40; lot#: 3054549.Cortical bone screw, 4x28mm; catalog#: 47-2486-128-40 ; lot#: 3076797.Cortical bone screw, 4x30mm; catalog#: 47-2486-130-40 ; lot#: 3073753.The manufacturer did not receive x-rays, or other source documents for review.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: 0009613350-2022-00243; 0009613350-2022-00244; 0009613350-2022-00245.Remains implanted.
Event or Problem Description
It was reported that operation was performed with nail.After 2 month from the initial, surgeon found #1 screw of the proximal screws was 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
This follow-up report is being submitted to relay additional and/or corrected information.Event description: it was reported that operation was performed with ann nail on (b)(6), 2022.After 2 month from the initial, surgeon found #1 screw of the proximal screws was 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.Patient involvement- no further outcome.Review of received data: - no medical records available.- due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.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.- 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.- 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.- a complaint history was run which identified additional complaints for the same product and lot number.Conclusion: it was reported that operation was performed with ann nail on (b)(6), 2022.After 2 month from the initial, surgeon found #1 screw of the proximal screws was 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.Patient involvement- no further outcome.The quality records show that all specified characteristics have met the specifications valid at the time of production.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).
Event or Problem Description
No change to previously reported event.

• Brand Name: BLUNT TIP SCREW, 4X48MM
• Common Device Name: AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL
• Manufacturer (Section D): ZIMMER SWITZERLAND MANFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANFACTURING 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: 14141249
• Report Number: 0009613350-2022-00246
• Device Sequence Number: 4025307
• Product Code: HSB
• UDI-Device Identifier: 00889024505483
• UDI-Public: 00889024505483
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181827
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/07/2022

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 Expiration Date: 08/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 47-2486-048-40
• Device Lot Number: 3024731
• 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: 03/25/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2020
• 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: Unknown