MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN KNIFELIGHT INSTRUMENT

Catalog Number UNK_SEL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 09/01/2005

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) of medical sciences, (b)(6). The title of this report is ¿mini open carpal tunnel release: a new technique using knifelight system. ¿ which is associated with the stryker ¿knifelight¿ system. Within that publication, intraoperatively/post-operative complications/ adverse events were reported which occurred from september 2005 to april 2009. It was not possible to ascertain specific device/patient 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 9 complaints were initiated retrospectively for different adverse events mentioned in the report. This product inquiry addresses sympathetic dystrophy. 4 out of 5 cases. The report states: ¿the late complications of pain induced by sympathetic dystrophy following surgery were diagnosed in 12 patients, of whom 7 cases were in group i and 5 cases were in group ii and they were all controlled by starting physical exercise, pain management using drugs such as corticosteroids and nerve stabilizers including gabapentin. ¿.

• Brand Name: UNKNOWN KNIFELIGHT
• Type of Device: INSTRUMENT
• 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 Key: 9235743
• Report Number: 0008031020-2019-01509
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: IR
• Number of Events Reported: 1
• 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 Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• 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 Received: 10/01/2019
• 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 Outcome(s): Required Intervention