MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANN, PROXIMAL HUMERUS, LEFT, 9X160MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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	07/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical devices: blunt tip screw, 4x36mm; item# 47-2486-036-40; lot# 3068947.Blunt tip screw, 4x38mm; item# 47-2486-038-40; lot# 3076829.Blunt tip screw, 4x38mm; item# 47-2486-038-40; lot# 3078220.Ann blunt tip screw 4x56mm; item# 47-2486-056-40; lot# 3091269.Ann cort bone screw 4 x 24mm; item# 47-2486-124-40; lot# 3080024.Ann cort bone screw 4 x 28mm; item# 47-2486-128-40; lot# 3081901.Affixus ph nl cap 10.5x2.5mm; item# 47-2488-010-02; lot# 3048838.Report source ¿ foreign: japan.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2022 ¿ 00390, 0009613350 - 2022 ¿ 00391, 0009613350 - 2022 ¿ 00392.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 the proximal screws were backed out from the proper position after 3 weeks from the initial surgery.No revision is planned so far.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h6.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.The investigation did not identify a non-conformance or a complaint out of box (coob).Based on the available information it is not possible to determine the root cause for this issue.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: ANN, PROXIMAL HUMERUS, LEFT, 9X160MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 15092242
• Report Number: 0009613350-2022-00389
• Device Sequence Number: 19842411
• Product Code: HSB
• UDI-Device Identifier: 00889024505810
• UDI-Public: (01)00889024505810(17)310714(10)3079658
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200814
• 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): 10/05/2022

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: 47-2496-161-09
• Device Lot Number: 3079658
• 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: 07/06/2022
• Supplement Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• 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