MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, LEFT, 11X160MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 ¿ medical devices: proximal humerus, left, 11x160mm; item# 47-2496-161-11; lot# 3134545.The following screws were implanted during the initial procedure, and it is unknown which has backed out: ann blunt tip screw 4x44mm; item# 47-2486-044-40; lot# 3076788, ann blunt tip screw 4x46mm; item# 47-2486-046-40; lot# 3076789, ann blunt tip screw 4x48mm; item# 47-2486-048-40; lot# 3008269.G2 ¿ foreign: japan.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2023 - 00563.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 the patient underwent an initial surgery, and approximately 6 months later, the surgeon found that one proximal screw was backed out from the proper position.The patient complained of pain, and a revision surgery was performed 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 information.H6: investigation findings: malfunction observed - c24.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.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 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.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, LEFT, 11X160MM
• 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: 17918283
• Report Number: 0009613350-2023-00562
• Device Sequence Number: 11486376
• Product Code: HSB
• UDI-Device Identifier: 00889024505827
• UDI-Public: (01)00889024505827(17)321123(10)3134545
• 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): 10/26/2023

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: N/A
• Device Catalogue Number: 47-2496-161-11
• Device Lot Number: 3134545
• 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: 09/20/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2022
• 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
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose