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 Irritation (1941)

Event Date 06/01/2003

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible.Based on the investigation, no definitive relation could be established between the product and the reported failure adverse consequence.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.Device evaluated by mfr: device disposition is unknown.

Event Description

The manufacturer became aware of a study from the department of (b)(6) infirmary, (b)(6).The title of this report is ¿evaluation of carpal tunnel release using the knifelight instrument¿ which was published in june 2003 and is associated with the stryker knifelight.Within that publication, post-operative complications/ adverse events were reported.It was not possible to ascertain specific device or patient information from the article; 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, 22 complaints were initiated retrospectively for different adverse events mentioned in the study.This product inquiry addresses mild scar tenderness.11 out of 15 cases.

• 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: 8804713
• MDR Text Key: 151504108
• Report Number: 0008031020-2019-00900
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Other