MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MOTOCLIP; STAPLE

Catalog Number	1442-1814
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr was identified as part of complaint file remediation project.The doctor performed a surgery on (b)(6) 2017 and used a 18x14mm motoclip implant.Six (6) months post op the patient requested that the implant be removed and a revision surgery was performed.During the revision surgery, the doctor noticed the implant was loose and removed only the bridge.The clip legs remain in the patient.The doctor confirmed fusion by xray at the surgical site.The clip did not appear broken on the xray.No additional hardware was implanted during the revision surgery.Sem images confirmed a fatigue fracture likely while implanted as opposed to brittle fracture at removal.
Event or Problem Description
The doctor performed a surgery on (b)(6) 2017 and used a 18x14mm motoclip implant.Six (6) months post op the patient requested that the implant be removed and a revision surgery was performed.During the revision surgery, the doctor noticed the implant was loose and removed only the bridge.The clip legs remain in the patient.The doctor confirmed fusion by xray at the surgical site.The clip did not appear broken on the xray.No additional hardware was implanted during the revision surgery.

• Brand Name: MOTOCLIP
• Common Device Name: STAPLE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis TN 38119
• MDR Report Key: 9406431
• Report Number: 3011421599-2019-00016
• Device Sequence Number: 2166859
• Product Code: JDR
• UDI-Device Identifier: 00850310006106
• UDI-Public: 00850310006106
• Combination Product (Y/N): N
• PMA/510(K) Number: K142727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2019

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?: No
• Operator of Device: No Information
• Device Catalogue Number: 1442-1814
• Device Lot Number: 1010687
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention