MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH WASHER SMALL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a shoulder surgery ,and approximately 6 months later a revision surgery was done due to the screw loosening and got unscrewing.The anterior oblique was also loose but did not unscrewed like the transverse one.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 47-2486-050-40 3068483 blunt tip screw 4x50mm.47-2488-000-04 3008331 ann washer small.47-2486-052-40 3024745 blunt tip screw 4x52mm.47-2496-260-07 3008140 ann proximal humerus, right 7x260mm.Report source¿ foreign ¿belgium.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2022 - 00382, 0009613350 - 2022 - 00381, 0009613350 - 2022 - 00387.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: WASHER SMALL
• 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: 15093020
• Report Number: 0009613350-2022-00384
• Device Sequence Number: 19842417
• Product Code: HSB
• UDI-Device Identifier: 00889024505599
• UDI-Public: (01)00889024505599(17)241031(3008331)
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K181827
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/20/2022

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: 10/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 47-2488-000-04
• Device Lot Number: 3008331
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2019
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown