MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP PAC DISPOSABLE; ACCESSORIES,ARTHROSCOPIC

Model Number	7209874
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dantas p, gonçalves s, mascarenhas v, camporese a, marin-peña o.Hip arthroscopy with initial access to the peripheral compartment provides significant improvement in fai patients.Knee surg sports traumatol arthrosc.2021 may;29(5):1453-1460.Doi: 10.1007/s00167-020-06380-z.Epub 2021 jan 2.Pmid: 33386879.(b)(4).
Event or Problem Description
It was reported that on literature review ¿hip arthroscopy with initial access to the peripheral compartment provides significant improvement in fai patients.¿; after surgery, one patient had revision for iliotibial band release.Paper indicates smith&nephew device was used, however no malfunction was reported during use.
Additional Manufacturer Narrative
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.Insufficient product identification information was provided, and thus, a manufacturing record review could not be conducted.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.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.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: HIP PAC DISPOSABLE
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12436382
• Report Number: 1219602-2021-01881
• Device Sequence Number: 3579028
• Product Code: NBH
• UDI-Device Identifier: 03596010529596
• UDI-Public: 03596010529596
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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: 7209874
• Device Catalogue Number: 7209874
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 10/21/2021
• 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: Other