MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN ASNIS III TITANIUM CANNULATED SCREW; IMPLANT

Catalog Number UNK_SEL

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

Patient Problems Erythema (1840); Unspecified Infection (1930); Pain (1994)

Event Date 03/01/2011

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.

Event Description

The manufacturer became aware of a study from (b)(6) hospital, (b)(6).The title of this study is ¿percutaneous screw fixation for painful non-union of lateral malleolus ankle fractures¿ and is associated with the stryker asnis iiitm titanium screw.Within that publication, intraoperative/ post-operative complications/ adverse events were reported, which occurred between march 2011 to february 2017.It was not possible to ascertain specific device catalogs 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 3 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses superficial infection and pain.The study states: ¿one patient (8%) was treated with 7 days of oral antibiotics for a presumed superficial surgical site infection.The diagnosis was made on the grounds of erythema surrounding the wound and an increase in pain noted at the two week review appointment.The pain and erythema fully resolved during the course of antibiotics and the fracture united uneventfully.¿.

• Brand Name: UNKNOWN ASNIS III TITANIUM CANNULATED 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: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8732906
• MDR Text Key: 149147229
• Report Number: 0008031020-2019-00739
• Device Sequence Number: 1
• Product Code: HWC
• 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: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• 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: 05/31/2019
• 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): Required Intervention
• Patient Age: 36 YR