MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO POINTER, KNEE NAVIGATION; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	6003-011-000
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the service evaluation process conducted at the manufacturer facility the led lens of the device was identified as broken off.No patient involvement or procedural delays were associated with the event as the event occurred during the evaluation process.
Additional Manufacturer Narrative
The reported event that led cover is also broke off was confirmed by the device evaluation.During the visual inspection it was observed that the large led lens was broken off.Any physical impact to the navigated instrument can cause product damage.
Event or Problem Description
It was reported that during the service evaluation process conducted at the manufacturer facility the led lens of the device was identified as broken off.No patient involvement or procedural delays were associated with the event as the event occurred during the evaluation process.

• Brand Name: POINTER, KNEE NAVIGATION
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 6375757
• Report Number: 0001811755-2017-00699
• Device Sequence Number: 13703666
• Product Code: OLO
• UDI-Device Identifier: 04546540246028
• UDI-Public: (01)04546540246028
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K022579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Replace,Repair,Relabeling,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2017

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: Other
• Device Catalogue Number: 6003-011-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2017
• Supplement Report FDA Received Date: 03/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1