MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX BROAD STRAIGHT 7-HOLE FRACTURE PLATE; IMPLANT

Catalog Number UNK_SEL

Device Problem Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.

Event Description

While performing a revision of the patient's right clavicle, a variax broad straight 7-hole fracture plate was implanted.While using the correct drill and drill guide, the locking threads of the locking screw would not engage in the plate.The screw was removed and a second screw attempted, and the screw again would not engage in the plate.After evaluating patient's stability, surgeon decided to leave the 2nd screw in.Surgery was completed with a delay of approximately 1 minute.No adverse consequences reported.

• Brand Name: UNKNOWN VARIAX BROAD STRAIGHT 7-HOLE FRACTURE PLATE
• 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: 8900418
• MDR Text Key: 161695503
• Report Number: 0008031020-2019-01062
• Device Sequence Number: 1
• Product Code: HRS
• 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: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 07/22/2019
• 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