MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX DISTAL RADIUS LOCKING SCREW; IMPLANT

Catalog Number UNK_SEL

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Code Available (3191)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

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 results, no definitive relation could be established between the product and the reported failure adverse consequence.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information will be provided.If further relevant information becomes available, the investigation will be reevaluated and resubmitted accordingly.Device evaluated by mfr: device disposition is unknown.

Event Description

The manufacturer became aware of a post-market clinical follow-up (pmcf) report from (b)(6) medical center, (b)(6).The title of this report is ¿a post market clinical follow-up (pmcf) of the treatment of wrist fractures with the stryker variax distal radius locking plate system¿ which was published in june 2019 and is associated with the stryker variax distal radius locking plate system.Within that publication, post-operative complications/ adverse events were reported which occurred between 2012 and 2018.It was not possible to ascertain specific device or patient information 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, 12 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses distal locking screw protrusion.The study reports: ¿in the study population, 4 patients experienced device related adverse events.All of those were found in the post-operative period.[¿] the third patient had a distal locking screw that protruded through the articular surface secondary to settling at the fracture site.This was first noted at three months post op.At this stage in the patient¿s recovery, the fracture was healed, and the hardware was kept in place, as it was asymptomatic.[¿] all complications have been resolved.Hardware irritation is a known complication of distal radius fixation.The patient who had the screw migrate through the articular surface and the patient who had a screw break both went on to fracture consolidation.

• Brand Name: UNKNOWN VARIAX DISTAL RADIUS LOCKING SCREW
• 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: 8817712
• MDR Text Key: 152020129
• Report Number: 0008031020-2019-00921
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 07/05/2019
• 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