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

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: proximal humerus, left, 9x160mm: catalog: 47249616109; lot: 3058647.Blunt tip screw, 4x42mm: catalog:47248604240; lot: 3076740.Blunt tip screw, 4x44mm: catalog: 47248604440; lot: 3076741.Blunt tip screw, 4x40mm: catalog: 47248604040; lot: 3054469.Blunt tip screw, 4x40mm; catalog: 47248604040; lot: 3068920.Blunt tip screw, 4x42mm: catalog: 47248604240; lot: 3039349.Blunt tip screw, 4x54mm: catalog: 47248605440; lot: 3024757.Cortical bone screw, 4x26mm: catalog: 47248612640; lot: 3068970.Cortical bone screw, 4x28mm: catalog: 47248612840; lot: 3054458.Proximal humerus nail cap, 0mm: catalog: 47248801000; lot: 3068924.Report source - foreign: (b)(6).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: 0009613350-2022-00277, 0009613350-2022-00290, 0009613350-2022-00291.
Event or Problem Description
It was reported, that: operation was performed with ann nail.After 5 months from the initial, surgeon found one of the proximal screws was backed out from the proper position.The surgeon keep an eye on the patient condition as well as no revision will be planned so far.
Additional Manufacturer Narrative
(b)(4) this follow-up report is being submitted to relay additional information.As no product was 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.Medical records were not provided.Further possible contributing factors to the migration of the screw might be related to either patient condition, behaviour or implantation procedure.A definitive root cause cannot be determined.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 or Problem Description
No further event information available at the time of this report.

• 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: 14445941
• Report Number: 0009613350-2022-00289
• Device Sequence Number: 4519540
• Product Code: HSB
• UDI-Device Identifier: 00889024505452
• UDI-Public: (01)00889024505452(17)260517(10)3073795
• 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: 2021
• 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): 07/12/2022

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: Health Professional
• Device Expiration Date: 05/17/2026
• Device Model Number: N/A
• Device Catalogue Number: 47-2486-042-40
• Device Lot Number: 3073795
• 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: 07/11/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• 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