MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN ASNIS III 6MM SCREW, LENGTH 55-85MM; IMPLANT

Catalog Number UNK_SEL

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

Patient Problem Thrombosis (2100)

Event Date 11/27/2018

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) which was published on 27-november-2018.The title of this report is ¿percutaneous screws ct guided to fix sacroiliac joint in tile c pelvic injury.Outcomes at 5 years of follow-up¿ which is associated with the stryker asnis screw system.Within that publication, postoperative complications/ adverse events were reported.It was not possible to ascertain specific device catalog or patient 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 26 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses deep vein thrombosis within the first 3 months post-op.10 out of 11 cases.The study states, ¿about 11.3% of the patients developed non-clinically significant deep vein thrombosis within the first 3 months post-op, despite anti-thromboembolic prophylaxis.These were diagnosed by performing lower limb echo-doppler scans following onset of symptoms and clinical evaluation.¿.

• Brand Name: UNKNOWN ASNIS III 6MM SCREW, LENGTH 55-85MM
• 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: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9247239
• MDR Text Key: 178364239
• Report Number: 0008031020-2019-01559
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• 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: 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 Sequence Number: 1
• Patient Outcome(s): Other