MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CORTICAL BONE SCREW, ÿ 4X28MM; AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL

Model Number	N/A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical product: blunt tip screw, 4x44mm; catalog#: 47-2486-044-40; lot#: 3010653.Blunt tip screw, 4x46mm; catalog#: 47-2486-046-40; lot#: 3024714.Blunt tip screw, 4x60mm; catalog#: 47-2486-060-40; lot#: 3054546.Proximal humerus nail cap, 0mm; catalog#: 47-2488-010-00; lot#: 3033538.The manufacturer received x-rays and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2022-00126; 0009613350-2022-00127; 0009613350-2022-00129.
Event or Problem Description
It was reported that operation was performed with ann nail system.After 4 months from the initial, surgeon found a screw 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.Patient involvement.No further outcome.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information investigation results are now available.During the investigation it was concluded that the device previously submitted on this medwatch is not a contributing element for the reported event and therefore has been moved to concomitant device.Please remove 0009613350-2022- 00128 from your records.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00126-1, 3068920 0009613350-2022-00129-1, 0009613350-2022- 00216, 0009613350-2022-00217.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
Investigation results are now available.During the investigation it was concluded that the device previously submitted on this medwatch is not a contributing element for the reported event and therefore has been moved to concomitant device.Please remove 0009613350-2022- 00128 from your records.

• Brand Name: CORTICAL BONE SCREW, ÿ 4X28MM
• Common Device Name: AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL
• 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: 13666846
• Report Number: 0009613350-2022-00128
• Device Sequence Number: 20022669
• Product Code: HSB
• UDI-Device Identifier: 00889024505346
• UDI-Public: 00889024505346
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2022

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: 03/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 47-2486-128-40
• Device Lot Number: 3068488
• 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: 02/11/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2021
• 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: Hospitalization
• Patient Sex: Female