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

Model Number N/A

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 01/12/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision due to migration.

Manufacturer Narrative

Customer has indicated that the screw which was revised is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: blunt tip screw, 4x52mm catalog: 47-2486-052-40; lot: 3024748.Blunt tip screw, 4x46mm catalog: 47-2486-046-40; lot: 3024720.Blunt tip screw, 4x46mm catalog: 47-2486-046-40; lot: 3039375.Proximal humerus nail cap, 0mm catalog: 47-2488-010-00; lot: 3076775.Cortical bone screw, 4x24mm catalog: 47-2486-124-40; lot: 3068968.Cortical bone screw, 4x26mm catalog: 47-2486-126-40; lot: 3048178.Cortical bone screw, 4x28mm catalog: 47-2486-128-40; lot: 3054458.Spider washer catalog: 47-2488-000-05; lot: 3054287.Zimmer reference: (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00182.

Manufacturer Narrative

Investigation results were made available.Event description: it was reported that the patient underwent surgery with an affixus natural nail on (b)(6) 2021.Two weeks post-implantation, the surgeon found the first most proximal screw backed out from the proper positon.Six weeks post-implantation, the patient experienced pain in the affected area during rehabilitation.Therefore, a revision surgery was performed on (b)(6) 2022 and the migrated screw was explanted.The corelock mechanism was noted as being engaged.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requx-rays: two undated preoperative ap x-rays of the right humerus have been received showing the humeral fracture.Two undated postoperative ap x-rays showing the implant placement has been received.An ann spider washer has been utilized for the most proximal screw.Two preoperative ap x-rays dated on (b)(6) 2022 were received which show lateral migration of the most proximal blunt tip screw when compared with the two undated postoperative x-rays.Two ct 3d scans were received showing migration of the most proximal screw.One of these scans is undated, whereas the other is dated on (b)(6) 2022.Images: four images of the explanted blunt tip screw were received.Product evaluation: visual examination: the explanted blunt tip screw was returned for investigation.A visual examination was performed and minimal signs of wear along the thread flanks can be seen, with several threads flanks being flattened, indicating contact between the screw and nail and screw migration.Refer to the pictures attached below.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: 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 the patient underwent surgery with an affixus natural nail on (b)(6) 2021.Two weeks post-implantation, the surgeon found the first most proximal screw backed out from the proper positon.Six weeks post-implantation, the patient experienced pain in the affected area during rehabilitation.Therefore, a revision surgery was performed on (b)(6) 2022 and the migrated screw was explanted.The corelock mechanism was noted as being engaged.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.This phenomenon is supported by the visual examination of the received screw, which shows slightly flattened and polished thread flanks, likely occurring due to direct contact between the screw and the nail.No further medical documents such as surgical reports or office visit notes have been received.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, 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.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00182-1.

Event Description

Investigation has been completed.

• Brand Name: BLUNT TIP SCREW, 4X42MM
• Type of Device: 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: 13888931
• MDR Text Key: 288670726
• Report Number: 0009613350-2022-00181
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47-2486-042-40
• Device Lot Number: 3054509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/13/2021
• 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.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 31 KG