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

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: proximal humerus, left, 9x160mm item# 47-2496-161-09 lot# 3082275; blunt tip screw, 4x44mm item# 47-2486-044-40 lot# 3091268; blunt tip screw, 4x46mm item# 47-2486-046-40 lot# 3076744.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 - 00682; 0009613350 - 2022 - 00684; 0009613350 - 2023 - 00004.
Event or Problem Description
It was reported that the patient underwent a revision surgery of the hip due to migration, approximately one (1) month post-op.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.As no products were returned, visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.Two views of the left shoulder demonstrate transverse fracture involving the proximal humeral diaphysis with involvement of the greater tuberosity.Intramedullary rod with multiple screws.Possible backing out of the proximal to screws.Overall fit and alignment of the implant is appropriate.Mild osteopenia.Possible backing out of the two proximal humeral screws.No surgical report was provided.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.An additional deeper investigation was performed which identified the design limitation of the corelock mechanism of the nail as a potential contributing factor.As part of the deeper investigation, a scientific literature search was conducted and a systematic review of the outcome of intramedullary nailing for acute proximal humerus fracture showed that screw migration and perforation into the joint is the second most common complication following secondary loss of reduction.In addition, scientific literature of competitor and predicate devices were assessed.This review has shown that the nail proximal humeral system performs better and/or in equal range in comparison with legally marketed similar devices.Therefore, 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.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.

• Brand Name: BLUNT TIP SCREW, 4X42MM
• Common Device Name: ROD, FIXATION
• 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: 16120004
• Report Number: 0009613350-2022-00683
• Device Sequence Number: 17768482
• Product Code: HSB
• UDI-Device Identifier: 00889024505452
• UDI-Public: (01)00889024505452(17)260729(10)3078230
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/29/2026
• Device Model Number: N/A
• Device Catalogue Number: 47-2486-042-40
• Device Lot Number: 3078230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 55 KG