MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP POINTER, STRAIGHT; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 6007-011-000

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2023

Event Type  malfunction  

Event Description

Per the customer, the trigger part of the pointer came off before cleaning.The screw that held the trigger in place is also unknown.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.

Event Description

Per the customer, the trigger part of the pointer came off before cleaning.The screw that held the trigger in place is also unknown.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.

Manufacturer Narrative

Device evaluation: follow-up report submitted to document the device evaluation.

• Brand Name: POINTER, STRAIGHT
• Type of Device: 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: 17875267
• MDR Text Key: 324964019
• Report Number: 3015967359-2023-02068
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04546540392114
• UDI-Public: 04546540392114
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 6007-011-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 90 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian