MAUDE Adverse Event Report: ZIMMER GMBH BLUNT TIP SCREW, ÿ 4X44MM; PROSTHESIS, TRAUMA

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D.10: proximal humerus, right, ã¿ 11x160mm item#47249616011 lot# 3137800 blunt tip screw, ã¿ 4x42mm item#47-2486-042-40 lot#3155804; ann blunt tip screw 4x42mm item#47-2486-042-40 lot#3152737; ann blunt tip screw 4x60mm item#47-2486-060-40 lot#3091607; ann cort bone screw 4 x 30mm item# 47-2486-130-40 lot#3155767; ann cort bone screw 4 x 32mm item# 47-2486-132-40 lot#3091574; affixus ph nl cap 0mm item#47-2488-010-00 lot#3158999.G2.Report source: japan.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.Multiple mdr reports were filed for this event, please see associated reports: medwatch's: 0009613350-2023-00643; 0009613350-2023-00645.
Event or Problem Description
It was reported that operation was performed with ann nail on sep 12, 2023.After 4 weeks from this surgery, surgeon found #1 and #2 proximal screws were backed out from the proper position.The surgeon keeps an eye on the patient condition as well as no revision will be planned so far.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: d4(udi); e1; e2; e3; g3; h2; h3; h6.Corrected: b5; h4.Two radiographs were provided and reviewed by a radiologist.Two views of the right humerus demonstrate an intramedullary rod with multiple fixation screw; the proximal two fixation screws have withdrawn.Comminuted fracture of the proximal humeral diaphysis with lucent fracture line still seen.Glenoid osteophytosis and steopenia.Overall fit and alignment of the implants is appropriate.Perhaps the screws backed out because of the incompletely healed fracture.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.A definitive root cause is unable to be determined 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
It was reported that patient presented approximately 4 weeks post initial surgery and it was found that two proximal screws have backed out of the ann nail system.At this time, no revision surgery is planned.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: BLUNT TIP SCREW, ÿ 4X44MM
• Common Device Name: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER 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: 18184686
• Report Number: 0009613350-2023-00644
• Device Sequence Number: 7568325
• Product Code: HSB
• UDI-Device Identifier: 00889024505469
• UDI-Public: (01)00889024505469(17)260729(10)3076788
• 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): 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/29/2026
• Device Model Number: N/A
• Device Catalogue Number: 47248604440
• Device Lot Number: 3076788
• 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: 10/27/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2021
• 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: SEE H10
• Patient Sex: Unknown