MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GRAFTMASTER TISSUE GRASPERS; TEMPLATE

Model Number	014412
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).
Event or Problem Description
It was reported that during surgery, a graftmaster tissue grasper was noticed rust.The procedure was finished using a competitor device.It is unknown if this problem caused surgical delay.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the subject device and the reported incident.A complaint history review concluded this was a repeat issue.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A review of the customer provided image found the laser etching on the device confirmed the part number.Discoloration can be seen on the upper jaw of the device.The complaint was confirmed, but the root cause could not be established.Factors that could have contributed to the reported event include improper storage or transport conditions or improper routine maintenance of the device.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: GRAFTMASTER TISSUE GRASPERS
• Common Device Name: TEMPLATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12391120
• Report Number: 1219602-2021-01816
• Device Sequence Number: 5361153
• Product Code: HWT
• UDI-Device Identifier: 03596010025784
• UDI-Public: 03596010025784
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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: 014412
• Device Catalogue Number: 014412
• Device Lot Number: 50785638
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1