MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG LOCKING SCREW, T7, 2.7X20MM; PLATE, FIXATION, BONE

Catalog Number 53-27620S

Device Problems Difficult to Insert (1316); Device Slipped (1584); Positioning Problem (3009)

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

Event Date 08/18/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that the screws backed out from the variax distal radius plate and the plate had to be removed from the patient.The surgeon further reported that he was unsure if the screws had been tightened correctly.Procedure undertaken ¿ variax distal radius.Date of original surgery ¿ (b)(6) 2016.Patient activity post implantation ¿ plaster backslab 4 weeks with finger/thumb.Movement only then mobilisation.Reduction difficult due to delayed presentation, non-anatomic position accepted.Procedure carried out by my trainee with consultant, it¿s possible that the locking screws were not optimally tight.The surgeon reported that he has found that the variax screws need to be checked/tightened at the end of the fixation as some are often not fully seated despite a locking screw construct.Patient details: (b)(6), female, overweight, epilepsy.

• Brand Name: LOCKING SCREW, T7, 2.7X20MM
• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6260804
• MDR Text Key: 65101153
• Report Number: 0008010177-2017-00011
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K080667
• 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: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 53-27620S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2016
• 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: 49 YR