MAUDE Adverse Event Report: MAKO SURGICAL CORP. SCAPULAR CLAMP; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE.

Catalog Number	190661
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received from upper extremity sales team: coracoid fracture happened during the case when dr.Put the clamp onto the coracoid during the mako rsa.Update: the coracoid clamp was applied using the common shoulder driver.When the pa tightened the common shoulder driver the coracoid fractured.Nothing unusual about the use of the common shoulder driver- just the handle was tightened to firmly.Fracture did not seem to be too severe and was fixed with some fiber wire.

• Brand Name: SCAPULAR CLAMP
• Common Device Name: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE.
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24894725
• Report Number: 3005985723-2026-00188
• Device Sequence Number: 9899620
• Product Code: HXD
• UDI-Device Identifier: 07613327595482
• UDI-Public: 07613327595482
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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: 190661
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown