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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the customer when doctor went to put tibial tracker for a total knee replacement surgery, the pin broke as it was being drilled into the tibia.The pin broke at the base of the threaded area inside the patient's tibia.After completing the surgery, doctor had us bring in a c-arm, and he was able to get the threaded portion of the pin out of the patient's tibia.The doctor had to retrieve the pin with an extra, small incision.He then packed the small hole in the patient's tibia with bone putty.The procedure was completed successfully without a clinically significant delay; no adverse consequences were reported.
Additional Manufacturer Narrative
Update: d9, h3, h6 correction: follow-up report submitted to document the device was not available for evaluation.H3 other text : device not returned.
Event or Problem Description
Per the customer when doctor went to put tibial tracker for a total knee replacement surgery, the pin broke as it was being drilled into the tibia.The pin broke at the base of the threaded area inside the patient's tibia.After completing the surgery, doctor had us bring in a c-arm, and he was able to get the threaded portion of the pin out of the patient's tibia.The doctor had to retrieve the pin with an extra, small incision.He then packed the small hole in the patient's tibia with bone putty.The procedure was completed successfully without a clinically significant delay; no 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-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 18170478
• Report Number: 3015967359-2023-02488
• Device Sequence Number: 7611566
• Product Code: HAW
• UDI-Device Identifier: 54546540503225
• UDI-Public: 54546540503225
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2024

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?: Yes
• Device Catalogue Number: 6007103110
• Device Lot Number: AA2449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 01/01/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown