MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AMR TIP ARM DRCTR ACL GDE; ACCESSORIES,ARTHROSCOPIC

Model Number	7205519
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zipcode (b)(6).
Event or Problem Description
It was reported that during an acl surgery, the acufex drill guide was not lined up.There was not a back-up available and it is unknown how the procedure was completed.There was no delay and no patient injuries reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10.H3, h6: the reported director drill guide aimer, used 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 aimer did not align properly.An exact root cause cannot be determined with confidence without the return of the device.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: AMR TIP ARM DRCTR ACL GDE
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9565610
• Report Number: 1219602-2020-00051
• Device Sequence Number: 2197565
• Product Code: NBH
• UDI-Device Identifier: 03596010373281
• UDI-Public: 03596010373281
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 02/19/2020

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: 7205519
• Device Catalogue Number: 7205519
• Device Lot Number: 50676399
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1