MAUDE Adverse Event Report: ZIMMER GMBH BLUNT TIP SCREW, ÿ 4X38MM; IMPLANT, TRAUMA

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D4.Product id was provided for three screws however, it is unknown which two of the three screws have migrated.Therefore, the migrates screws can be any of the following: 47248603840 ¿ blunt tip screw ¿ 3200109; udi: (b)(4); manufacturing date: apr 08, 2024; expiration date: apr 08, 2029.47248603840 ¿ blunt tip screw ¿ 3202502; udi: (b)(4); manufacturing date: apr 22, 2024; expiration date: apr 22, 2029.47248603640 ¿ blunt tip screw - 3185167; udi: (b)(4); manufacturing date: nov 27, 2023; expiration date: nov 27, 2028.D10.Proximal humerus, right, long, ã¿ 8.5x220mm item# 47249622008 lot# 3178811.Blunt tip screw, ã¿ 4x38mm item# 47248603840 lot# 3200109.Blunt tip screw, ã¿ 4x36mm item# 47248603640 lot# 3185167.Cortical bone screw, ã¿ 4x24mm item# 47248612440 lot# 3197002.Cortical bone screw, ã¿ 4x26mm item# 47248612640 lot# 3200539.Proximal humerus nail cap, ã¿ 10.5x2.5mm item# 47248801002 lot# 3189231.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.
Event or Problem Description
It was reported that an initial operation was performed with ann nail system and after 3 weeks, surgeon found two of the 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.Diligence is completed and no further information on the reported event has been provided.
Event or Problem Description
No additional event information.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h10, h11 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.Review of the complaint histories identified additional similar complaints for the reported items and the part and lot combinations.Complaints are monitored in order to identify potential adverse trends.Radiographs were provided and reviewed by a radiologist.Assessment of imaging: 9/2/24- an intramedullary nail with proximal and distal screws traverses a right humeral diaphyseal fracture.Alignment is anatomic.9/18/24- since prior exam 2 of the 3 proximal fixation screws have significantly retracted.Nail position is unchanged.While the views are not identical, there may be slight interval increase in fracture angulation.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 corrective action.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.

• Brand Name: BLUNT TIP SCREW, ÿ 4X38MM
• Common Device Name: IMPLANT, 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: 20522091
• Report Number: 0009613350-2024-00498
• Device Sequence Number: 9105421
• Product Code: HSB
• UDI-Device Identifier: 00889024505438
• UDI-Public: (01)00889024505438(17)290422(10)3202502
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181827
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 11/14/2024

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 Model Number: N/A
• Device Catalogue Number: 47248603840
• Device Lot Number: 3202502
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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 H11 NARRATIVE.
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 40 KG