MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURER GMBH BLUNT TIP SCREW, 4X40MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	47-2486-040-40
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	05/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item#: 47-2496-280-08; lot#: 3123159; item name: proximal humerus, right, long, 8.5x280mm.Item#: 47-2486-042-40; lot#: 3087855; item name: blunt tip screw, 4x42mm.Item#: 47-2486-044-40; lot#: 3091417; item name: blunt tip screw, 4x44mm.Item#: 47-2486-124-40; lot#: 3136308; item name: blunt tip screw, 4x44mm.Item#: 47-2486-124-40; lot#: 3137797; item name: blunt tip screw, 4x44mm.Item#: 47-2488-010-00; lot#: 3091320; item name: blunt tip screw, 4x44mm.Item#: 27923; lot#: 3091320; item name: torque limiting handle.G2-foreign- japan.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 -2023 -00254, 0009613350 -2023 -00256, 0009613350 -2023 -00257.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 during the initial surgery, the patient was implanted with ann nail.6 weeks after the surgery one of the proximal screws was backed out from the proper position and the patient experienced pain.Subsequently, the patient underwent revision surgery to remove the migrated screw.Attempts have been made and no further information has been provided.
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 and/or corrected information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h10.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 that could be related to the reported event.Devices are used for treatment.Images were provided and reviewed by a health care professional.Fluoroscopic image demonstrates the proximal aspect of a right humeral im nail and proximal screw with anatomic alignment.Right humeral images demonstrate intramedullary nail and screw fixation of the right humerus with near anatomic alignment of the diaphyseal fracture.The most proximal screw appears to have retracted significantly from the humerus but is still engaged by the nail.No loosening, wear or abnormal radiolucency is noted.Implant fit and alignment are maintained apart from retraction of the most proximal screw as noted.Bone quality is osteopenic patient anatomy appears unremarkable.There is no evidence of interval trauma.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.Of note, as confirmed from the x-rays, no ascending screw was used during surgery.The use of this screw increase primary stability of the implant and supports the humeral heal during abduction.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, ascientific 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 thesecond 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.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: BLUNT TIP SCREW, 4X40MM
• 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: 17115407
• Report Number: 0009613350-2023-00255
• Device Sequence Number: 15213495
• Product Code: HSB
• UDI-Device Identifier: 00889024505445
• UDI-Public: (01)00889024505445(17)261208(10)3091516
• 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
• Device Explanted 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): 06/14/2023

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 Model Number: 47-2486-040-40
• Device Catalogue Number: 47-2486-040-40
• Device Lot Number: 3091516
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male