MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ORTHOLOCK EX-PIN 3 X 110; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6007103110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgical procedure at the user facility an ortholock pin was broken off in the tibia of the patient.The pin was intentionally left in the tibia to prevent further harm at the discretion of the surgeon.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Event or Problem Description
It was reported that during a surgical procedure at the user facility an ortholock pin was broken off in the tibia of the patient.The pin was intentionally left in the tibia to prevent further harm at the discretion of the surgeon.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document the device was discarded by the customer, no evaluation is possible.

• Brand Name: ORTHOLOCK EX-PIN 3 X 110
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8635947
• Report Number: 0001811755-2019-01785
• Device Sequence Number: 11199565
• Product Code: HAW
• UDI-Device Identifier: 34546540503221
• UDI-Public: 34546540503221
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2019

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: 6007103110
• Device Lot Number: Y47920
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1