MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GRAFTMASTER III SLIDING BASE ASSY; TEMPLATE

Model Number	72202316
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
(b)(6).
Event or Problem Description
It was reported that during an acl surgery, the acufex graftmaster 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
Product graftmaster iii sliding base assy used during treatment, was not returned for evaluation.Due to product unavailability, investigation was limited.If objective evidence, relevant information, packaging or product becomes available to assist with evaluation, the complaint may be revisited.Factors that may affect device performance include: device ability, surgical ability, implant location and tissue condition.Review of instruction for use documentation confirms instructions, precautionary statements and recommendations for proper use of product.Potential reason for the failure may be wear or damage to mating components.Per instructions for use: as with any surgical instrument, careful attention should be made to assure that excessive force is not placed on the instrument.Excessive forces applied to the instrument can result in instrument failure.Complaint history review indicated no similar allegations for the lot number reported.Device history review/batch/lot review did not indicate a condition or product/procedure failure that supported the allegation.Product met specifications upon release to distribution.

• Brand Name: GRAFTMASTER III SLIDING BASE ASSY
• Common Device Name: TEMPLATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9565500
• Report Number: 1219602-2020-00050
• Device Sequence Number: 19539374
• Product Code: HWT
• UDI-Device Identifier: 03596010651129
• UDI-Public: 03596010651129
• 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: 72202316
• Device Catalogue Number: 72202316
• Device Lot Number: 50430950
• 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