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

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after 2 months from the initial surgery, the surgeon found that the #1 and #3 proximal screws had migrated out of the proper position.The patient complained of pain and revision surgery was performed to remove the migrated screws.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D4: product id was provided for three screws however, it is unknown which of the three screws has migrated.Therefore, the migrated screw could be any of the following: 47248603440 - blunt tip screw, ã¿ 4x34mm - 3181269; udi: (b)(4); manufacturing date: nov 2, 2023; expiration date: nov 2, 2028.47248603840 - blunt tip screw, ã¿ 4x38mm - 3190919; udi: (b)(4); manufacturing date: jan 24, 2024; expiration date: jan 24, 2029.47248604240 - ann blunt tip screw 4x42mm - 3185190; udi: (b)(4); manufacturing date: dec 5, 2023; expiration date: dec 5, 2028.D10: 47249622108 - proximal humerus, left, long, ã¿ 8.5x220mm - 3177532; 47248603440 - blunt tip screw, ã¿ 4x34mm - 3181269; 47248604240 - ann blunt tip screw 4x42mm - 3185190; 47248612440 - ann cort bone screw 4 x 24mm - 3193267; 47248801000 - affixus ph nl cap 0mm - 3189255.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.

• Brand Name: BLUNT TIP SCREW, ÿ 4X38MM
• Common Device Name: TRAUMA, INSTRUMENTS.
• 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: 19994475
• Report Number: 0009613350-2024-00378
• Device Sequence Number: 7075536
• Product Code: HSB
• UDI-Device Identifier: 00889024505438
• UDI-Public: (01)00889024505438(17)290124(01)3190919
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2024

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: 47248603840
• Device Lot Number: 3190919
• 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: 07/23/2024
• Initial Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2024
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown