MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. CANN SCREW 2.0 X 40MM CANN SCREW; SCREW, FIXATION, BONE

Model Number 03-4001-40

Device Problem Device Inoperable (1663)

Patient Problem Visual Disturbances (2140)

Event Date 01/10/2017

Event Type  Injury  

Manufacturer Narrative

The device has been returned to the manufacturer for evaluation.Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.

Event Description

Allegedly, it was reported that the patient underwent a proximal interphalangeal joint arthrodesis.It was reported that the cannulated screws were not getting purchase in the bone as they should.The surgeon needed to use a k-wire to complete the surgery.As a result, the patient will have to deal with a k-wire coming out of the skin.No additional patient complications were reported.

Manufacturer Narrative

The device was evaluated.Visual examination of the screws does not show any overall gross deformation.However, it was noted that the head of both the screws had some wear and the shaft of one of the screws has some wear.Dimensional evaluation of basic overall dimensions indicates that the screws were manufactured to specification.

• Brand Name: CANN SCREW 2.0 X 40MM CANN SCREW
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; 38002
• Manufacturer Contact: matthew parrish ; 1023 cherry road; 901451-631
• MDR Report Key: 6287334
• MDR Text Key: 66114510
• Report Number: 1043534-2017-00010
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 03-4001-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/10/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2017
• Supplement Dates Manufacturer Received: 11/14/2017
• Supplement Dates FDA Received: 11/14/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other