MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BLT ASSY, ANGLED,DIRECTOR ACL; ACCESSORIES,ARTHROSCOPIC

Model Number	7205524
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a cruciate ligament reconstruction surgery, the kirschner wire broke in the angle director and couldn¿t be pulled out.No patient injury was reported.
Additional Manufacturer Narrative
One director drill guide angled bullet was returned for evaluation.Visual assessment confirmed a portion of a passing pin remains within the bullets cannulation.The broken passing pin is lodged where the cannulation transitions down in size and cannot be removed.As reported the passing pin used in conjunction with the bullet was not a smith+nephew device.The director drill guide angled bullet is designed to be used with compatible smith+nephew guidewires or passing pins.User error may have contributed to this event.

• Brand Name: BLT ASSY, ANGLED,DIRECTOR ACL
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7547267
• Report Number: 1219602-2018-00657
• Device Sequence Number: 13496894
• Product Code: NBH
• UDI-Device Identifier: 03596010373267
• UDI-Public: (01)03596010373267(10)50595950
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7205524
• Device Catalogue Number: 7205524
• Device Lot Number: 50595950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 05/27/2018
• Supplement Report FDA Received Date: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 83