MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS LLC MOTOCLIP SUPERELASTIC FUSION SYSTEM; SINGLE/MULTIPLE COMPONENT BONE FIXATION APPLIANCE, BONE STAPLE

Model Number UNKNOWN

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation were inconclusive based on the information available and the evaluation of the x-ray.Part#/lot# of fractured staple is unknown.It is unknown if the patient followed the surgeon's instructions for weight bearing.There are multiple lots of clips which were involved in this case.It is unknown which lot of clip experienced mechanical failure.It also appears as if there is possible mechanical failure of the plate and a screw.All part and lot number information for all the implants involved will be posted below.P/n: 1418-2222, lot: 101497, udi: (b)(4), expiration date: 07/08/2018, description: motoclip implant kit 18mm x 22mm x 22mm.P/n: 1418-2222, lot: 101956, udi: (b)(4), expiration date: 01/23/2019, description: motoclip implant kit 18mm x 22mm x 22mm.P/n: 1418-1818, lot: 101854, udi: (b)(4), expiration date: 12/16/2018, description: motoclip implant kit 18mm x 18mm x 18mm.P/n: 7100-rd18, lot: 102026, udi: (b)(4) expiration date: n/a, description: dynaforce vero plate distal plate 18mm.P/n: 1500-3022, lot: 101428, udi: (b)(4), expiration date: 05/01/2021, description: motoband cp locking screw 3.0mm x 22mm.P/n: 1500-3024, lot: 101429, udi: (b)(4), expiration date: 04/01/2021, description: motoband cp locking screw 3.0mm x 24mm.

Event Description

Original date of surgery - (b)(6) 2017.Failure detection date - 10/25/2017.Post-operative follow up visit discovered one nitionol staple fracture per surgeon, patient has fused and is not experiencing any pain or discomfort from mechanical failure.Revision surgery not scheduled nor expected.Patient initially underwent surgery to correct a charcot foot.Patient's contralateral leg was amputated at the hip at an early age.This likely led to patient bearing weight earlier than recommended and resulted in the mechanical failure of the construct.

• Brand Name: MOTOCLIP SUPERELASTIC FUSION SYSTEM
• Type of Device: SINGLE/MULTIPLE COMPONENT BONE FIXATION APPLIANCE, BONE STAPLE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS LLC; 6055 primacy parkway; suite 140; memphis TN 38119
• Manufacturer Contact: vernon hartdegen ; 6055 primacy parkway; suite 140; memphis, TN 38119 ; 9012218406
• MDR Report Key: 8465669
• MDR Text Key: 146263771
• Report Number: 3011421599-2017-00008
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• PMA/PMN Number: K142727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2017
• 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 Age: 45 YR
• Patient Weight: 118