MAUDE Adverse Event Report: Synthes GmbH INSRT HNDL FOR MULTILOC HUM NLING SYS; Rod, Fixation, Intramedullary And Accessories

Catalog Number	03.019.006
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Malfunction

• Brand Name: INSRT HNDL FOR MULTILOC HUM NLING SYS
• Common Device Name: Rod, Fixation, Intramedullary And Accessories
• Manufacturer (Section D): Synthes GmbH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): Monument; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50114871
• Report Number: 8030965-2026-07895
• Device Sequence Number: 10076145
• Product Code: HSB
• UDI-Device Identifier: 10886982069436
• UDI-Public: (01)10886982069436(10)8210911
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K103002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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: Health Professional
• Device Catalogue Number: 03.019.006
• Device Lot Number: 8210911
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: 08/04/2026; 09/04/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 08/05/2026; 09/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown