MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SOD,AIMER,ACL,FMRL,ANTERIOR LTRL ENTRY; ACCESSORIES,ARTHROSCOPIC

Catalog Number	6901189
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during acl procedure, all devices were assembled.When a guide wire pass through, using a bullet, the tips of guide wire and aimer were misaligned.It seems that tip of aimer deformed.The procedure was completed with the same device.60 minutes delay was reported.There was not patient injury, harm or complications during or after the procedure.
Additional Manufacturer Narrative
One 6901189 lateral entry anterior femoral acl aimer returned.This is identified as a ¿made to order, special order¿ item.The complaint stated: ¿all devices were assembled.When a guide wire pass through, using a bullet, the tips of guide wire and aimer were misaligned.It seems that tip of aimer deformed.¿ mating parts 7205517/50745756, 7205519/50742223, 7205524/50708480, 7205525/50711223 were not returned.As the original mating components were not returned, the source of the mismatch was visually confirmed.The tip of device is not completely plane.S+n is aware of the potential offset.Dimensional and functional evaluation of this system has been performed by engineering.A process improvement is underway to improve the manufacturing process which includes an additional flatness check on the aimer with the goal to improve and align knee arthroscopy drill guide aimer family final inspection processes to adequately control alignment between the guide wire and the target on the aimer.Ensure controls are aligned with the refurbishing department.No further investigation is warranted at this time.

• Brand Name: SOD,AIMER,ACL,FMRL,ANTERIOR LTRL ENTRY
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8151490
• Report Number: 1219602-2018-01722
• Device Sequence Number: 16567537
• Product Code: NBH
• UDI-Device Identifier: 03596010560438
• UDI-Public: 03596010560438
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

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: 6901189
• Device Lot Number: 50618961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1