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	07/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the ortholock ex-pin's end broke off in the left tibia bone canal.The surgeon decided to not remove the broken tip as it was determined the removal can incur more harm than benefit and that the broken pin inside the tibia bone will have no impact to the patient's outcome.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.
Event or Problem Description
It was reported that during a procedure, the ortholock ex-pin's end broke off in the left tibia bone canal.The surgeon decided to not remove the broken tip as it was determined the removal can incur more harm than benefit and that the broken pin inside the tibia bone will have no impact to the patient's outcome.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.

• 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: 8974792
• Report Number: 0001811755-2019-02932
• Device Sequence Number: 18879051
• Product Code: HAW
• UDI-Device Identifier: 34546540503221
• UDI-Public: 34546540503221
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2019

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: No Information
• Device Catalogue Number: 6007103110
• Device Lot Number: Y47918
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1