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

Catalog Number	47-2496-160-09
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	08/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2-foreign-japan.D10.The following screws were implanted during the initial procedure, and it is unknown which screw exactly had backed out: item#: 47-2486-036-40; lot#: 3091452; item name: blunt tip screw, 4x36mm; item#: 47-2486-038-40; lot#: 3086931; item name: blunt tip screw, 4x38mm; item#: 47-2486-040-40; lot#: 3147804; item name: blunt tip screw, 4x40mm; item#: 47-2486-044-40; lot#: 3091413; item name: blunt tip screw, 4x44mm; item#: 47-2486-044-40; lot#: 3091415; item name: blunt tip screw, 4x44mm.Multiple mdr reports were filed for this event, please see the associated reports: 0009613350-2023-00498.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that five weeks post-implantation one of the screws backed out from the proper position.The patient complained of pain and revision surgery was performed to remove the migrated screw.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.H2.Investigation findings: malfunction observed.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Devices are used for treatment.The product combination was approved by zimmer biomet.The surgical technique explains that the locking of the corelock is done using the corelock driver with torque limiting handle."turn slowly clockwise to tighten and engage the corelock mechanism until a click is felt from the torque limiting handle." review of complaint history identified additional similar complaints for the reported items and additional similar complaints for the reported part and lot combinations.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Medical records were not provided.It can be assumed that multiple contributing factors, related to either patient condition and behavior or implantation procedure, contributed to the migration of the screws.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 corelock mechanism of the affixus 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 affixus® natural nail® proximal humeral system performs better and/or in equal range in comparison with legally marketed similar devices.In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the migration of the screw.No corrective actions, preventive actions, or field actions resulted after investigation of this event as this issue was already addressed in a previously ca.Multiple mdr reports were filed for this event, please see associated reports: medwatch: 0009613350-2023-00498.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: PROXIMAL HUMERUS, RIGHT, 9X160MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURER 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: 17648582
• Report Number: 0009613350-2023-00501
• Device Sequence Number: 7278464
• Product Code: HSB
• UDI-Device Identifier: 00889024505780
• UDI-Public: (01)00889024505780(17)321007(10)3128403
• 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: 2023
• 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): 11/17/2023

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 Catalogue Number: 47-2496-160-09
• Device Lot Number: 3128403
• 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: 08/04/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose