MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX HAND LOW PROFILE PLATE; IMPLANT

Catalog Number UNK_SEL

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

Patient Problem Swelling (2091)

Event Date 01/01/2001

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.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.Based on the available information, no relation could be established between the device and the reported event.Based on the investigation, no definitive relation could be established between the product and the reported failure adverse consequence.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 (b)(6) university, (b)(6).The title of this report is ¿open reduction and low-profile plate and/or screw fixation in the treatment of phalangeal fractures¿ which was published in march 2009 and is associated with the stryker variax hand plating system.Within that publication, post-operative complications/ adverse events were reported, which occurred between 2001 to 2007.In the provided study, products from two manufacturers, one of them being stryker, were used.It cannot be determined whether the reported adverse events are related to stryker products.It was not possible to ascertain specific device or patient information from the study; 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, 13 complaints were initiated retrospectively for different adverse events mentioned in the study.This product inquiry addresses permanent swelling.1 out of 4 cases.The study reports: ¿in 11 fractures (61,1%), at least one or more complications were seen.Permanent swelling occurred in the surgery area in 4 fingers.[.] 7 major (tarm<180°; 38,8%) and 6 minor (tarm between 180 and 195° in 4 patients and delayed union in 2 patients; 33,3%) complications were identified.Major complications occurred in 3 (27,2%) of the 11 fingers fixed with screws, and in 4 (%57,1) of the 11 fingers which received plate screw fixation.[.] a significant cause of patient dissatisfaction in our study was permanent swelling in the operated fingers.

• Brand Name: UNKNOWN VARIAX HAND LOW PROFILE PLATE
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8809891
• MDR Text Key: 151711322
• Report Number: 0008031020-2019-00912
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• 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: 07/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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