MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG CANNULATED COMPRESSION SCREW; PLATE, FIXATION, BONE

Catalog Number 58-30420

Device Problem Failure to Advance (2524)

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

Event Date 11/15/2016

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

The screw itself would no longer advance only the blue portion.The proximal would advance and not the gold.

Manufacturer Narrative

The reported event that cannulated compression screw was alleged of 'cold welding' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by the application of excessive force on the device.The device inspection revealed that both parts of the screw, gold and blue, are cold welded.Additionally the screw presents some damages in the threads.This could only occur if the screw is exposed to high torsional forces.Note that this can happen if it is not used a tap before inserting the screw.Usinf a tap is something recommended by the ifu in order to avoid such cases.Note, as stated in the ifu (90-01927): ¿¿ screw tap 07-40232 must be used when inserting the screw implant into very hard bone in order to prevent rounding of the head of the screw.¿ [original statement(s)] a review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.

Event Description

The screw itself would no longer advance only the blue portion.The proximal would advance and not the gold.

• Brand Name: CANNULATED COMPRESSION SCREW
• 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: 6149806
• MDR Text Key: 61869249
• Report Number: 0008010177-2016-00285
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013775
• 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: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 58-30420
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 49 YR