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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN KNIFELIGHT INSTRUMENT

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STRYKER GMBH UNKNOWN KNIFELIGHT INSTRUMENT Back to Search Results
Catalog Number UNK_SEL
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Date 05/01/2011
Event Type  Injury  
Manufacturer Narrative
This complaint has been reported during a literature review performed by the post market surveillance group. The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available. More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. The device history record could not be reviewed because the affected lot number was not communicated. If any further information is provided, the investigation report will be updated. Device disposition is unknown.
 
Event Description
The manufacturer became aware of a study from (b)(6). The title of this report is ¿complications of the surgical treatment of carpal tunnel syndrome using the ¿knifelight¿ system. ¿ which is associated with the stryker ¿knifelight¿ system. Within that publication, post-operative complications/ adverse events were reported which occurred from may 2011 to january 2012. It was not possible to ascertain specific device details from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 6 complaints were initiated retrospectively for different adverse events mentioned in the report. This product inquiry addresses incomplete release of carpal annular ligament followed by a revision surgery. 1 out of 2 cases. The report states: ¿(b)(6) years old patient, that came to the consultation due to the persistence of the symptoms of compression of the right median nerve, after surgical release of the cts using knifelight®, ten months ago. Surgical exploration of the carpal canal was performed through a palmar approach, and incomplete opening of the flexor retinaculum, in its distal portion, was observed. After its division, we proceeded to the interposition of an hypothenar fat pad flap according to the technique described by cramer in 1985. ¿.
 
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Brand NameUNKNOWN KNIFELIGHT
Type of DeviceINSTRUMENT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer (Section G)
STRYKER ENDOSCOPY-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 00615
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9235746
MDR Text Key176950357
Report Number0008031020-2019-01514
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeES
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 10/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/24/2019 Patient Sequence Number: 1
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