MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HDL ASSY DRCTR ACL GDE.; ACCESSORIES,ARTHROSCOPIC

Catalog Number	7205517
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was defective.Prior to drilling the tibial tunnel, we could not assemble the guide due to the fact that the bullet was not able to slide into the guide handle.The procedure was completed with a competitor device.No patient injuries were reported.
Additional Manufacturer Narrative
One (b)(4) acl guide distractor handle assembly returned.The complaint stated: ¿we could not assemble the guide due to the fact that the bullet was not able to slide into the guide handle.¿ the set screw was removed at the compression spring and retainer lock area.The retainer lock was found overtightened which would not allow bypass of the bullet component.It is unknown how or when this component became locked/frozen in this position.There are no other complaints for this lot or allegation.This is considered an isolated incident.Root cause related to the manufacture of this device was not confirmed.

• Brand Name: HDL ASSY DRCTR ACL GDE.
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8336020
• Report Number: 1219602-2019-00191
• Device Sequence Number: 11267032
• Product Code: NBH
• UDI-Device Identifier: 03596010373250
• UDI-Public: 03596010373250
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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 Catalogue Number: 7205517
• Device Lot Number: 50758817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1