MAUDE Adverse Event Report: ZIMMER GMBH ANTE/RETROGRADE HUMERUS, ÿ 9.5X280MM; IMPLANT, TRAUMA

Catalog Number	47-2497-280-09
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cortical bone screw, #item 47248612440, #lot 3167005; blunt tip screw, #item 47248604640, #lot 3152738; ante/retrograde humerus nail cap, #item 47248800800, #lot 3010698; blunt tip screw, #item 47248603840, #lot unknown, therapy date: unknown.G2: switzerland.Attempts have been made to gather all product identification information and no further information has been provided.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 at 6 month follow up was experiencing moderate pain and had a non-union fracture.The patient is reported as improved/recuperated.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
Follow up report (b)(4).Updated: b4,b5,d2,d9,g1,g3,g6,h1,h2,h3,h6 corrected: d4 no product was returned or pictures provided; a product evaluation could not be performed.The reported products were reviewed for compatibility with no issues noted.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Medical records were not provided.A definitive root cause could not be determined.No corrective, preventive or field action was taken following the investigation of this event.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
No additional event information.

• Brand Name: ANTE/RETROGRADE HUMERUS, ÿ 9.5X280MM
• Common Device Name: IMPLANT, TRAUMA
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21875708
• Report Number: 0009613350-2025-00326
• Device Sequence Number: 8742361
• Product Code: HSB
• UDI-Device Identifier: 00889024506220
• UDI-Public: (01)00889024506220(17)300630(10)3031575
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K231114
• 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): 09/25/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 47-2497-280-09
• Device Lot Number: 3031575
• 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: 04/04/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2020
• 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: Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 60 KG