MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP INSTRUMENT CLAMP ELECTROMAGNETIC UNIVER.; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 8000060021

Device Problems Imprecision (1307); Incorrect Measurement (1383)

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

Event Date 05/24/2022

Event Type  malfunction  

Event Description

Per the customer the device did not track accurately and was off by over 3mm during a procedure.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

Manufacturer Narrative

Update: d9, h3, h6.Device evaluation: follow-up report submitted to document device evaluation results.

Event Description

Per the customer the device did not track accurately and was off by over 3mm during a procedure.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: INSTRUMENT CLAMP ELECTROMAGNETIC UNIVER.
• 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: 14744024
• MDR Text Key: 295887171
• Report Number: 3015967359-2022-01181
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 07613327512298
• UDI-Public: 07613327512298
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

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
• Device Model Number: 8000060021
• Device Catalogue Number: 8000-060-021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/20/2022
• Supplement Dates Manufacturer Received: 08/09/2022
• Supplement Dates FDA Received: 08/10/2022
• 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: Initial
• Patient Sequence Number: 1