MAUDE Adverse Event Report: STRYKER GMBH ASNIS MICRO CANNULATED SCREW, 3.0-MM DIA; IMPLANT

Catalog Number UNK_SEL

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Failure of Implant (1924)

Event Date 08/01/2015

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device evaluated by mfr: device disposition is unknown.

Event Description

The manufacturer became aware of a study from ¿1st orthopaedic department, university of (b)(6)¿ which was published in august 2015.The title of this study is ¿treatment of scaphoid waist nonunion using olecranon bone graft and stryker asnis micro cannulated screw¿ and is associated with the asnis micro cannulated screw system.Within that publication, post-operative complications/ adverse events were reported.It was not possible to ascertain specific device details from the report; a review of the complaint handling database, however, revealed that the event has not been reported by the hospital or by the author of the publication.Therefore, 84 complaint was initiated retrospectively for the different adverse event mentioned in the report.This product inquiry addresses nonunion.3 out of 8 cases.The study states: "eight patients developed partial graft resorption with persistent nonunion.¿.

• Brand Name: ASNIS MICRO CANNULATED SCREW, 3.0-MM DIA
• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8601233
• MDR Text Key: 144806581
• Report Number: 0008031020-2019-00421
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_SEL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2019
• 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