MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANN, BLUNT TIP SCREW, 4X42MM; ROD, FIXATION, INTRAMEDULLARY

Model Number 47-2486-042-40

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: cortical bone screw, 4x26mm; catalog#47248612640; lot#3091271.Cortical bone screw, 4x28mm; catalog#47248612840; lot#3082043.Proximal humerus nail cap, 0mm; catalog#47248801000; lot#3082050.Torque limiting handle; catalog#27923; lot#unknown.Report source: foreign: japan.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00369, 0009613350-2022-00371, 0009613350-2022-00372, 0009613350-2022-00373.

Event Description

It was reported that the surgeon found that the proximal screw was backed out from the proper position 1 month after the initial surgery.The surgeon will continue to monitor the patient's condition.Revision surgery is not currently planned.No further patient outcome was provided.Attempts have been made and no further information has been provided yet.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, g3, g6, h1, h2, h6, h10.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.Devices are used for treatment.No surgical report or x-rays are available for investigation.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, behavior 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.In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the migration of the screw.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 available at the time of this report.

• Brand Name: ANN, BLUNT TIP SCREW, 4X42MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 15014034
• MDR Text Key: 295875161
• Report Number: 0009613350-2022-00370
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024505452
• UDI-Public: (01)00889024505452(17)260508(10)3073793
• 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: 09/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 47-2486-042-40
• Device Catalogue Number: 47-2486-042-40
• Device Lot Number: 3073793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• 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
• Patient Outcome(s): Other