MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X42MM; AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 10/11/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: concomitant medical products therapy date: b)(6) 2021.Cortical bone screw, ã¿ 4x28mm; catalog#: 47248612840; lot#: 3054458.Cortical bone screw, ã¿ 4x28mm; catalog#: 47248612840; lot#: 3064872.Proximal humerus nail cap, 0mm; catalog#: 47248801000; lot#: 3068909.Torque limiting handle; catalog#: 27923; lot#: unknown.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: 0009613350-2021-00582, 0009613350-2021-00583, 0009613350-2021-00585.

Event Description

It was reported that a revision surgery was performed due to migration.

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Updated: h2, h6, h10.Event description: it was reported that the patient had an ann nailing system implanted on (b)(6) 2021.It was confirmed that the corelock mechanism was engaged with the torque handle after placing all the interlocking screws.Two months after the implantation, the #2 blunt screw backed out from the original position.The screw was removed during revision surgery performed on (b)(6) 2021.Review of received data: - no medical data relevant to the case has been received.- due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: - the screw was discarded by the hospital; therefore, visual evaluation could not be performed.The nail remained implanted.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 sap: 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: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that the patient had an ann nailing system implanted on (b)(6) 2021.It was confirmed that the corelock mechanism was engaged with the torque handle after placing all the interlocking screws.Two months after the implantation, the #2 blunt screw backed out from the original position.The screw was removed during revision surgery performed on (b)(6) 2021.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).Based on the investigation it can be assumed that the factors that led and/or contributed to the migration of the screw might be multifactorial related to either patient condition, behaviour, 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.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).

• Brand Name: BLUNT TIP SCREW, 4X42MM
• Type of Device: 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: 12834730
• MDR Text Key: 280930664
• Report Number: 0009613350-2021-00584
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024505452
• UDI-Public: 00889024505452
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47-2486-042-40
• Device Lot Number: 3010647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/18/2021
• Supplement Dates Manufacturer Received: 12/09/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention