MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANN, PROXIMAL HUMERUS, RIGHT, LONG, 8.5X240MM; AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL

Model Number N/A

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 05/02/2022

Event Type  Injury  

Event Description

It was reported that the surgeon found that 2 of the proximal screws were backed out from the proper position approximately 1 month after the implantation.The surgeon is keeping an eye on the patient's condition and no revision is planned so far.Harm not reported.Attempts have been made and no further information has been made available at this time.

Manufacturer Narrative

(b)(4).Ann, blunt tip screw, 4x40mm; catalog# 47248604040; lot#3068919.Ann, blunt tip screw, 4x44mm; catalog# 472486044-40; lot#3076805.Ann, blunt tip screw, 4x46mm; catalog#47248604640; lot#3068905.Cortical bone screw, 4x22mm; catalog#47248612240; lot#3068948.Cortical bone screw, 4x22mm; catalog#47248612240; lot#3073758.Cortical bone screw, 4x24mm; catalog#47248612440; lot#3078178.Torque limiting handle; catalog#27923; lot#unknown.Foreign: (b)(6).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00317 0009613350-2022-00318 0009613350-2022-00319.

Manufacturer Narrative

As no product was returned, visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.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.The investigation also considered whether the design limitation of the corelock mechanism could be a potential contributing factor.However, further biomechanical testing identified that the product performance is in an acceptable range in comparison with legally marketed similar devices.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

No further event information is available at the time of this report.

• Brand Name: ANN, PROXIMAL HUMERUS, RIGHT, LONG, 8.5X240MM
• 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: 14601582
• MDR Text Key: 293346428
• Report Number: 0009613350-2022-00315
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024505964
• UDI-Public: (01)00889024505964(17)300331(10)3026936
• 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,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• 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: 47-2496-240-08
• Device Lot Number: 3026936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/27/2020
• 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): Other