MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW 4X46MM; AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL

Model Number 47-2486-046-40

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 02/07/2022

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet reference: (b)(4).The device will not be returned for analysis.Investigation results are now available.Concomitant medical products: cortical bone screw catalog# 47-2486-126-40; lot 3068970, cortical bone screw catalog# 47-2486-128-40; lot: 3068488, torque limiting handle catalog#27923;lot: n/a, proximal humerus nail cap, 0mm; catalog#: 47-2488-010-00; lot#: 3033538.Investigation and conclusion: event description: it was reported that the patient underwent primary operation with an affixus natural nail on (b)(6) 2021.Four months later, it was discovered that the second most proximal screws migrated from the initial position despite the utilization of the corelock mechanism.The patient is being monitored and no revision surgery has been planned so far.Harm: s2 - instability, minor hazardous situation: implant deteriorates, breaks or loses function postoperatively.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: two undated postoperative ap x-rays of the affected humerus have been received.One of the images shows the implant placement presumably directly post-implantation.The second image in comparison shows the second most proximal screw having migrated laterally.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 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.- 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 primary operation with an affixus natural nail on (b)(6) 2021.Four months later, it was discovered that the second most proximal screws migrated from the initial position despite the utilization of the corelock mechanism.The patient is being monitored and no revision surgery has been planned so far.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 second most proximal screw has migrated.No further medical documents such as surgical reports or office visit notes nor the complained product itself have been received.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.Multiple mdr reports were filed for this event, associated reports: 0009613350-2022-00126-1, 0009613350-2022-00127 (device moved to concomitant, report voided), 0009613350-2022-00128 (device moved to concomitant, report voided), 3068920 0009613350-2022-00129-1, 0009613350 -2022 -00216.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that ann nail system was implanted and 4 months after the initial procedure, the surgeon found that a proximal screw had backed out from the proper position.No revision surgery.No further outcome for the patient.Investigation results are now available.Attempts have been made and no further information has been provided.The device here reported was added as main product after the investigation was completed.

• Brand Name: BLUNT TIP SCREW 4X46MM
• 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: 14019779
• MDR Text Key: 288652204
• Report Number: 0009613350-2022-00217
• 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: K181827
• 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
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 47-2486-046-40
• Device Catalogue Number: 47-2486-046-40
• Device Lot Number: 3024714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2020
• 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