MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MOTOCLIP; STAPLE

Catalog Number	1418-1818
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was identified as part of complaint file remediation project.The doctor cut his hand on the leg of the inserter after the inserter broke during surgery.The doctor completed the facility's exposure control policy.The doctor is doing well and able to perform surgeries.The failure mode is a known risk of the device.Additional hardware used with the component previously listed: motoclip implant kit 18x18x18mm - sterile packaged part number 1418-1818; lot number 102001.
Event or Problem Description
The doctor cut his hand on the leg of the inserter after the inserter broke during surgery.The doctor completed the facility's exposure control policy.The doctor is doing well and able to perform surgeries.

• Brand Name: MOTOCLIP
• Common Device Name: STAPLE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis TN 38119
• MDR Report Key: 9410788
• Report Number: 3011421599-2019-00022
• Device Sequence Number: 14186537
• Product Code: JDR
• UDI-Device Identifier: 00815432023158
• UDI-Public: 00815432023158
• Combination Product (Y/N): N
• PMA/510(K) Number: K142727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/03/2019

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: 1418-1818
• Device Lot Number: 101842
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2018
• 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