MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG 2.7MM XXL VOLAR DR PLATE, NARROW, LEFT; PLATE, FIXATION, BONE

Catalog Number 54-25444

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 02/21/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The variax screw does not grasp into the plate.

Manufacturer Narrative

The ¿2.7mm xxl volar dr plate, narrow, left¿ is concomitant and did not contribute to the reported failure, as it was confirmed that during the surgery the wrong drill has been selected to drive the screws through the plate.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

Event Description

The variax screw does not grasp into the plate.

• Brand Name: 2.7MM XXL VOLAR DR PLATE, NARROW, LEFT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6423083
• MDR Text Key: 70791356
• Report Number: 0008010177-2017-00060
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K100271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 54-25444
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2017
• 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