MAUDE Adverse Event Report: STRYKER TRAUMA SELZACH SUPERELASTIC IMPLANT X FUSE STANDARD / ANGLE 15°; PIN, FIXATION, SMOOTH

Catalog Number AXFS15

Device Problem Packaging Problem (3007)

Patient Problem No Information (3190)

Event Date 05/18/2015

Event Type  malfunction  

Event Description

Empty product box.

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.Device will not be returned.

• Brand Name: SUPERELASTIC IMPLANT X FUSE STANDARD / ANGLE 15°
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4825950
• MDR Text Key: 5843226
• Report Number: 0008031020-2015-00230
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K070598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AXFS15
• Device Lot Number: F004019PCAE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: No
• 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