MAUDE Adverse Event Report: ORTHOFIX SRL ADV STRAIGHT CLAMP

Catalog Number	53530
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Received information stating that an lrs adv kit was delivered incomplete.As per reporter, the surgical procedure was completed using other items included in the kit, leading to a prolongation of the surgery by 45 minutes.As per the reporter, there was no patient harm.
Additional Manufacturer Narrative
No allegation of product malfunction was reported by user.
Additional Manufacturer Narrative
No allegation of product malfunction was reported by user.Investigation results confirmed the alleged event.
Event or Problem Description
Received information stating that an lrs adv kit was delivered incomplete.As per reporter, the surgical procedure was completed using other items included in the kit, leading to a prolongation of the surgery by 45 minutes.As per the reporter, there was no patient harm.

• Brand Name: ADV STRAIGHT CLAMP
• Common Device Name: ADV STRAIGHT CLAMP
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer Contact: elvira taccarelli ; via delle nazioni, 9; bussolengo, verona 37012 ; IT 37012
• MDR Report Key: 23691661
• Report Number: 9680825-2025-00052
• Device Sequence Number: 10375245
• Product Code: JDW
• UDI-Device Identifier: 18032568039900
• UDI-Public: 18032568039900
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K955848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: Health Professional
• Device Catalogue Number: 53530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown