MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS HIMAX; STAPLE

Catalog Number 7115-1818KT

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

The himax staple listed previously was used in conjunction with the following products as a total construct for joint arthrodesis: motoband max 4 hole plate, part #: 7100-4h15, lot #: 500065; motoband cp locking screw 3.0mm x 18mm, part #: 1500-3018, lot #: 102357; motoband cp non-locking screw 3.5mm x 22mm, part #: 1500-3522, lot #: 101416.

Event Description

Doctor performed a 1st tarsometatarsal (tmt) fusion procedure on (b)(6) 2019 where crossroads products were used.At some point post-surgery, the himax 15mm x 18mm x 18mm staples broke on the proximal leg in the medial cuneiform bone.Doctor says the joint experienced complete fusion.Patient at some point complained of pain and requested hardware removal.Doctor performed hardware removal on (b)(6) 2019 with no implantation of any products.

• Brand Name: HIMAX
• Type of Device: STAPLE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis TN 38119
• Manufacturer Contact: 6055 primacy parkway ste 140; memphis, TN 38119 ; 9012218406
• MDR Report Key: 9146012
• MDR Text Key: 163116509
• Report Number: 3011421599-2019-00012
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/19/2020
• Device Catalogue Number: 7115-1818KT
• Device Lot Number: 102867
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2018
• 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