MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AIMER ENDOFEMORAL 5MM OFFSET (RED); ACCESSORIES,ARTHROSCOPIC

Catalog Number	72201715
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during surgery the point of the wire broke during the passage in the bone.It is unknown if a back up device was available or if a delay was caused by the device malfunction, but no patient injuries were reported.
Additional Manufacturer Narrative
One 72201715 5mm offset endofemoral aimer instrument reported on.This is an eight year old reusable component.The product was not returned for evaluation.Physical conclusions, full investigation and evaluation were not possible.Factors affecting device performance include: device ability, surgical ability and surgical site preparation.Instrument tips may inadvertently be twisted or caught on other instruments or the basket during cleaning.This can lead to compromised strength.Final product met predetermined specifications upon release to distribution.
Additional Manufacturer Narrative
One 72201715 5mm offset endofemoral aimer used for treatment, was returned for evaluation.This is an eight year old reusable instrument.The product was received broken in two pieces.The entire aimer tip was fractured from the shaft.The entire laser weld was severed.There was evidence of weld.There was staining which indicated that the full fracture occurred over time.The aimer shaft was visibly bowed.A moderate amount of force was required to bend this substantial diameter shaft.The u slide channels have dents and material displaced from overtightening of the universal handle with the aimer.Excessive force can result in instrument failure.No root cause related to the manufacture of the device was established.Product met specifications upon release to distribution.

• Brand Name: AIMER ENDOFEMORAL 5MM OFFSET (RED)
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8519611
• Report Number: 1219602-2019-00433
• Device Sequence Number: 1966046
• Product Code: NBH
• UDI-Device Identifier: 03596010608208
• UDI-Public: 03596010608208
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2019

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: 72201715
• Device Lot Number: 50390875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 05/10/2019; 09/05/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/13/2019; 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1