MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NAV PIN 3MM X 150MM PACK OF 10; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6007003150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Paralysis (1997)
Date of Event	05/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a surgical procedure at the user facility the navigation pin was stuck too deep into the fibula.The procedure was completed successfully without a clinically significant delay; or medical intervention.It was further reported that a symptom like peroneal paralysis was observed after the procedure.Attempts are being made to obtain additional information from the user facility.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.Discarded by customer.
Event or Problem Description
It was reported that during a surgical procedure at the user facility the navigation pin was stuck too deep into the fibula.The procedure was completed successfully without a clinically significant delay; or medical intervention.It was further reported that a symptom like peroneal paralysis was observed after the procedure.Attempts are being made to obtain additional information from the user facility.

• Brand Name: NAV PIN 3MM X 150MM PACK OF 10
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7635706
• Report Number: 0001811755-2018-01089
• Device Sequence Number: 2143642
• Product Code: HAW
• UDI-Device Identifier: 37613154107408
• UDI-Public: 37613154107408
• Combination Product (Y/N): N
• PMA/510(K) Number: K022365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2018

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: 6007003150
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability