MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GRSPR ALGTR MAX; ACCESSORIES,ARTHROSCOPIC

Model Number	011024
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a knee arthroscopy surgery the grasper tip broke off.An additional incision was made in order to remove all the broken pieces.No other complications were reported.It is unknown if there was a delay and how the surgery was completed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3,h6: 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.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found the following warnings and precautions related to the reported failure: careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.Do not use these instruments as levers for manipulating hard tissue or bone.Excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects.A relationship, if any, between the subject device and the reported event could not be determined.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: GRSPR ALGTR MAX
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11330576
• Report Number: 1219602-2021-00325
• Device Sequence Number: 16349532
• Product Code: NBH
• UDI-Device Identifier: 03596010023056
• UDI-Public: 03596010023056
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 011024
• Device Catalogue Number: 011024
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 03/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention