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

Model Number	N/A
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.D10 - medical devices: ann blunt tip screw 4x44mm; item# 47-2486-044-40; lot# 3076741; ann blunt tip screw 4x44mm; item# 47-2486-044-40; lot# 3076742; ann blunt tip screw 4x44mm; item# 47-2486-044-40; lot# 3076788; ann blunt tip screw 4x54mm; item# 47-2486-054-40; lot# 3024756; ann cort bone screw 4 x 28mm; item# 47-2486-128-40; lot# 3091558; ann cort bone screw 4 x 32mm; item# 47-2486-132-40; lot# 3068973; affixus ph nl cap 0mm; item# 47-2488-010-00; lot# 3091320.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2022 ¿ 00615; 0009613350 - 2022 ¿ 00644; 0009613350 - 2022 ¿ 00645; 0009613350 - 2022 ¿ 00646.No product was returned or pictures provided: product evaluation could not be performed.Review of the manufacturing records identified no deviations or anomalies during manufacturing related to the reported event.Devices used for treatment.One undated x-ray image of the affected humerus was received and reviewed.The received x-rays shows what appears to be the most proximal screw having migrated.However, as no further x-ray images were received, no comparison or further assessment can be made regarding the migration of this screw.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.An additional deeper investigation was performed which identified the design limitation of the locking mechanism of the nail as a potential contributing factor.As part of the deeper investigation, a scientific literature search was conducted and a systematic review of the outcome of intramedullary nailing for acute proximal humerus fracture showed that screw migration and perforation into the joint is the second most common complication following secondary loss of reduction.In addition, scientific literature of competitor and predicate devices were assessed.This review has shown that the nail system performs better and/or in equal range in comparison with legally marketed similar devices.Therefore, 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PROXIMAL HUMERUS, RIGHT, 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
• MDR Report Key: 15876009
• Report Number: 0009613350-2022-00615
• Device Sequence Number: 14683544
• Product Code: HSB
• UDI-Device Identifier: 00889024505780
• UDI-Public: (01)00889024505780(17)310718(10)3079661
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2022

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: 47-2496-160-09
• Device Lot Number: 3079661
• 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): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 12/14/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown