MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MOTOCLIP; STAPLE

Catalog Number	7012-1212KT
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr was identified as part of complaint file remediation project.Non-union was discovered 9 months post-op.Site was revised (b)(6) 2018 with competitor product.All crossroads product was removed at that time.Hardware was used for an mcp joint in the hand.Original surgery date was (b)(6) 2017.The patient is an uncontrolled diabetic along with a 3 pack a day smoker.The hardware was well seated and fully intact when removed.Revision case was (b)(6) 2018 and the site was revised with a competitor product.No defects were identified for the implants.Non-union potentially related to patient factors (smoker; poor bone quality; uncontrolled diabetes).Additional hardware used with the component previously listed: dynaforce motoclip max kit 9x9x9mm part number 7009-0909kt lot number 500005.
Event or Problem Description
At 9 months post-op, a non-union was identified.A revision surgery was performed to replace the hardware.Original hardware was not broken.

• Brand Name: MOTOCLIP
• Common Device Name: STAPLE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis TN 38119
• MDR Report Key: 9410220
• Report Number: 3011421599-2019-00019
• Device Sequence Number: 16876318
• Product Code: JDR
• UDI-Device Identifier: 00815432023301
• UDI-Public: 00815432023301
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• 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: 7012-1212KT
• Device Lot Number: 500006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 12/04/2019
• 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
• Patient Age: 43 YR