MAUDE Adverse Event Report: STRYKER GMBH KNIFE LIGHT 10/PK; SURGICAL LAMP

Catalog Number	3300-001-000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Primary carpal tunnel release procedure, right wrist.As reported by facility's clinical manager: "[surgeon] was using a knife light today and the tip broke off in the patient.He has been using them for a while and feels like he did not do anything different, with this patient.Luckily he was able to retrieve the broken piece without difficulty.He feels this is very concerning." surgical delay of 30 seconds was report.Patient was visually inspected and device was re-assembled at the back table to ensure that all pieces were removed from the patient.Clinical manager indicated that the operative report is available, if needed.
Additional Manufacturer Narrative
The reported event that knife light 10/pk was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by inappropriate use of the device.The device inspection revealed the following: damages of the polymer tip are clearly evident, resulting that the blade detached slightly from the polymer structure.This was caused by the application of excessive force on the tip of the knife.This would probably be caused by using of the knifelight as a retracting device to pry or separate muscle or ligaments, which is a clear contradiction to what is recommended in the instruction for use.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
Primary carpal tunnel release procedure, right wrist.As reported by facility's clinical manager: "[surgeon] was using a knife light today and the tip broke off in the patient.He has been using them for a while and feels like he did not do anything different, with this patient.Luckily he was able to retrieve the broken piece without difficulty.He feels this is very concerning." surgical delay of 30 seconds was report.Patient was visually inspected and device was re-assembled at the back table to ensure that all pieces were removed from the patient.Clinical manager indicated that the operative report is available, if needed.

• Brand Name: KNIFE LIGHT 10/PK
• Common Device Name: SURGICAL LAMP
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7575483
• Report Number: 0008031020-2018-00425
• Device Sequence Number: 11391595
• Product Code: FTD
• UDI-Device Identifier: 34546540060113
• UDI-Public: 34546540060113
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K961122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2018

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: Health Professional
• Device Expiration Date: 10/23/2019
• Device Catalogue Number: 3300-001-000
• Device Lot Number: 17296FE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 08/23/2018
• 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: Other
• Patient Age: 55 YR
• Patient Weight: 126