MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURER GMBH ANN, PROXIMAL HUMERUS, RIGHT, 7X160MM; ROD, FIXATION

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: blunt tip screw, 4x42mm; item# 47248604240; lot# 3073795.Blunt tip screw, 4x42mm; item# 47248604240; lot# 3076740.Blunt tip screw, 4x44mm; item# 47248604440;lot# 3076741.Cortical bone screw, 4x30mm; item# 47248613040, lot# 3073753.Cortical bone screw, 4x32mm; item# 47248613240, lot# 3068973.Proximal humerus nail cap, 10.5x2.5mm; item# 47248801002; lot# 3068978.Report source¿ foreign ¿ (b)(6).No product return.Product remains implanted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00283, 0009613350-2022-00284, 0009613350-2022-00286.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.
Event or Problem Description
It was reported that one of the proximal screws backed out from the proper position one week after initial implantation.The surgeon is keeping an eye on the patient's condition.No revision surgery planned so far.No harm reported.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h6, h10.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.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.A deeper investigation was performed which identified the design limitation of the corelock mechanism as a potential contributing factor as well.However, further biomechanical testing was carried out and as the product 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.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ANN, PROXIMAL HUMERUS, RIGHT, 7X160MM
• Common Device Name: ROD, FIXATION
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURER 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: 14433193
• Report Number: 0009613350-2022-00282
• Device Sequence Number: 17616725
• Product Code: HSB
• UDI-Device Identifier: 00889024505773
• UDI-Public: (01)00889024505773(17)310930(10)3091683
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181827
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 07/26/2022

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 Model Number: N/A
• Device Catalogue Number: 47249616007
• Device Lot Number: 3091683
• 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: 04/21/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown