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

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a proximal screw migration was confirmed through x-ray 3.5 months after implantation surgery.It was also reported that patient has shoulder pain and the proximal screw had to be removed.No further outcome reported.Investigation results are now available.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: blunt tip screw, 4x40mm item#47-2486-040-40 lot#3073745.Blunt tip screw, 4x46mm item#47-2486-046-40 lot#3073670.Blunt tip screw, 4x38mm item#47-2486-038-40 lot#3073751.Cortical bone screw, 4x26mm ref: 47-2486-126-40; lot: 3073754.Cortical bone screw, 4x26mm ref: 47-2486-126-40; lot: 3078185.Report source: foreign - (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2022 - 00278, 0009613350 - 2022 - 00279, 0009613350 - 2022 - 00280.Investigation results are available.Device was not returned for analysis.Investigation and conclusion.Event description: it was reported that: humeral nail surgery on 20.12.2021, x-ray images (before/after).3.5 months after surgery - patient has left shoulder pain.After x-ray check, proximal screw migrated.Corelock was properly locked.Op technique was followed.Interventions to corelock were retrained again in jan.2022.The proximal screw was removed.Harm: s3 - instability, moderate hazardous situation: implant deteriorates, breaks or loses function postoperatively.Review of received data: no medical reports available.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: there is a x-ray picture available for investigation.The picture shows two different positioned views - there is a slight displacement of the implant position.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Surgical technique sap 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.Dhr review: the quality records show that all specified characteristics have met the specifications valid at the time of production with no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that: humeral nail surgery on (b)(6) 2021, x-ray images (before/after).3.5 months after surgery - patient has left shoulder pain.After x-ray check, proximal screw migrated.Corelock was properly locked.Op technique was followed.Interventions to corelock were retrained again in (b)(6) 2022.The proximal screw was removed.The quality records show that all specified characteristics have met the specifications valid at the time of production.The received x-rays confirm the reported event, namely that the most proximal screw has migrated.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.A deeper investigation was performed which identified the design limitation of the corelock mechanism as a potential contributing factor as well.However, further biomechanical testing was carried out and as the product performance is in an acceptable range in comparison with legally marketed similar devices, 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.
Additional Manufacturer Narrative
(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h6, h10 investigation results: - the involved blunt tip screw was returned for investigation.The visual examination of the returned screw shows signs of wear around the area of the hexagon socket.Additionally, minor polished thread flanks can be seen.This most likely occurred due to direct contact between the screw and the nail, which may point to screw migration.- all involved devices are intended for treatment.- the quality records show that all specified characteristics have met the specifications valid at the time of production.- the received x-rays confirm the reported event, namely that the most proximal screw has migrated.- 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.- in conclusion, as the cause may be multifactorial an exact root cause could not be identified for the migration of the screw.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PROXIMAL HUMERUS, LEFT, 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
• 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: 14370581
• Report Number: 0009613350-2022-00276
• Device Sequence Number: 19328375
• Product Code: HSB
• UDI-Device Identifier: 00889024505810
• UDI-Public: (01)00889024505810(17)310614(10)3067316
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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 Model Number: N/A
• Device Catalogue Number: 47-2496-161-09
• Device Lot Number: 3067316
• 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: 04/13/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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: D10, MEDICAL PRODUCT: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Unknown