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 Problem No Code Available (3191)

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 partial lesion of the median nerve. 1 out of 2 cases. The report states: ¿(b)(6) years old patient subject to surgical treatment for left cts, nine months ago. The patient experienced improvement of the symptoms of nocturnal paresthesias after the intervention, but referred dysesthesia on the palm, at the level of the proximal palmar crease and hypesthesia in the ulnar edge of the second finger and radial of the third. The examination showed a of positive tinel¿s sign in the proximal palmar crease, which gradually migrated to the distal crease over the months. The patient was treated by rehabilitation with local massage on the scar. ¿.

• 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: 9235761
• MDR Text Key: 176949171
• Report Number: 0008031020-2019-01519
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: ES
• 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 Treatment Data

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