MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AIMER ENDOFEMORAL 7MM OFFSET (GOLD); ACCESSORIES,ARTHROSCOPIC

Model Number	72201717
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the endo femoral aimer broke from the handle.There was no delay or patient injuries reported but it is unknown if a backup was available to complete the procedure.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported 7mm endofemoral aimer, intended for use in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the device broke.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied during use.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: AIMER ENDOFEMORAL 7MM OFFSET (GOLD)
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9272710
• Report Number: 1219602-2019-01370
• Device Sequence Number: 114635
• Product Code: NBH
• UDI-Device Identifier: 03596010608222
• UDI-Public: 03596010608222
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2021

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: 72201717
• Device Catalogue Number: 72201717
• Device Lot Number: 50595663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 12/03/2019; 05/04/2021
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 12/04/2019; 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1