MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ORTHOLOCK EX-PIN 3 X 110; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6007103110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Paresis (1998); Delirium (4592)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer, the tip of the fixation pin for anchoring the clamp support of navigation trackers broke into the tibia of the patient upon removal with the power tool.Per the surgeon's discretion, the tip was left in the bone.The procedure was completed successfully without a delay; no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a root cause could not be determined for the event.H3 other text : device not returned.
Event or Problem Description
Per the customer, the tip of the fixation pin for anchoring the clamp support of navigation trackers broke into the tibia of the patient upon removal with the power tool.Per the surgeon's discretion, the tip was left in the bone.The procedure was completed successfully without a delay; no medical intervention or adverse consequences were reported.

• Brand Name: ORTHOLOCK EX-PIN 3 X 110
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16768130
• Report Number: 0001811755-2023-00042
• Device Sequence Number: 11548121
• Product Code: HAW
• UDI-Device Identifier: 54546540503225
• UDI-Public: 54546540503225
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2023

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
• Device Catalogue Number: 6007103110
• Device Lot Number: K62111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown