MAUDE Adverse Event Report: STRYKER GMBH WASHER HOFFMANN LRF 4MM (BLUE); APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 49331712

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)

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

Event Date 06/21/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that during the procedure, 2 reference wires are put into the frame and were connected using rings and rods.The surgeon distracted to reduce the fracture using the wires.There was force going through the wires and this resulted in the blue washer becoming deformed.The procedure was completed using other items off the same set.

Manufacturer Narrative

The reported event that washer hoffmann lrf 4mm (blue) was alleged of 'device deformed' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by overloading the device (too much force applied).The device inspection revealed that the device is very deformed.The surgeon applied too much force and has damaged the part.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

Event Description

The customer reported that during the procedure, 2 reference wires are put into the frame and were connected using rings and rods.The surgeon distracted to reduce the fracture using the wires.There was force going through the wires and this resulted in the blue washer becoming deformed.The procedure was completed using other items off the same set.

• Brand Name: WASHER HOFFMANN LRF 4MM (BLUE)
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 6697521
• MDR Text Key: 79670589
• Report Number: 0008031020-2017-00402
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K113327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 49331712
• Device Lot Number: X26194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other