MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X46MM; 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 Failure of Implant (1924)

Event Date 01/14/2022

Event Type  Injury  

Event Description

It was reported that operation was performed with ann nail.After 3 weeks from the initial, patient started rehabilitaion aggressively.After 4 weeks, surgeon found #1 screw of the proximal screws was backed out from the proper position.Therefore, revision surgery was performed and the migrated screw was explanted.Outcome - revision due to migration.

Manufacturer Narrative

Concomitant medical products: proximal humerus, right, long, 8.5x240mm; catalog#: 47-2496-240-08; lot#: 3059713.Blunt tip screw, 4x44mm; catalog#: 47-2486-044-40; lot#: 3054485.Cortical bone screw, 4x26mm; catalog#: 47-2486-126-40; lot#: 3073720.Proximal humerus nail cap, 0mm; catalog#: 47-2488-010-00; lot#: 3073674.Blunt tip screw, 4x44mm; catalog#: 47-2486-044-40; lot#: 3010657.X-rays, photographs, were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned 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).

Manufacturer Narrative

Concomitant medical products: proximal humerus, right, long, 8.5x240mm; catalog#: 47-2496-240-08; lot#: 3059713.Blunt tip screw, 4x44mm; catalog#: 47-2486-044-40; lot#: 3054485.Cortical bone screw, 4x26mm; catalog#: 47-2486-126-40; lot#: 3073720.Proximal humerus nail cap, 0mm; catalog#: 47-2488-010-00; lot#: 3073674.Blunt tip screw, 4x44mm; catalog#: 47-2486-044-40; lot#: 3010657.X-rays, photographs, were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned 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).

Event Description

It was reported that operation was performed with ann nail.After 3 weeks from the initial, patient started rehabilitation aggressively.After 4 weeks, surgeon found #1 screw of the proximal screws was backed out from the proper position.Therefore, revision surgery was performed and the migrated screw was explanted.Outcome - revision 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.Event description: it was reported that operation was performed with ann nail on (b)(6) 2021.After 3 weeks from the initial, patient started rehabilitation aggressively.After 4 weeks, surgeon found #1 screw of the proximal screws was backed out from the proper position.Therefore, revision surgery was performed on (b)(6) 2022, and the migrated screw was explanted.Patient involvement - revision.No delay.The corelock mechanism was utilized.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: one x-ray was available.The x-ray confirms the migration of the most proximal screw.Images: several pictures were received.The pictures show the explanted screw.There are some damages on thread visible.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.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.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.Conclusion: it was reported that operation was performed with ann nail on (b)(6) 2021.After 3 weeks from the initial, patient started rehabilitation aggressively.After 4 weeks, surgeon found #1 screw of the proximal screws was backed out from the proper position.Therefore, revision surgery was performed on (b)(6) 2022, and the migrated screw was explanted.Patient involvement - revision.No delay.The corelock mechanism was utilized.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).The received x-ray and images confirm the reported event, namely that the most proximal screw has migrated.No product was returned; therefore, dimensional evaluation could not be performed.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.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, 4X46MM
• 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: 13523920
• MDR Text Key: 285989482
• Report Number: 0009613350-2022-00076
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024505476
• UDI-Public: 00889024505476
• 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: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2486-046-40
• Device Lot Number: 3024721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2020
• 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
• Patient Outcome(s): Required Intervention; Hospitalization