MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN DISPOSABLE BLADE AND BURR; SAW, POWERED, AND ACCESSORIES

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 03/04/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case- (b)(4).Article: micheli, l.J., solomon, r., solomon, j., gearhart, m., zwicker, r., & sugimoto, d.(2021).Posterior ankle decompression with os trigonum or stieda process resection in dancers: case series report and review of the literature.The journal of foot and ankle surgery.

Event Description

It was reported that on literature review ¿posterior ankle decompression with os trigonum or stieda process resection in dancers: case series report and review of the literature ¿, after surgery with a dyonics powermini 2.9mm cutter blade arthroscopic shaver one patient had superficial infection requiring antibiotics.No further information is available.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).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.Insufficient product identification information was provided and thus a manufacturing record review, complaint history review, ifu/device labeling review and risk management review could not be conducted.Without supporting clinical/medical documents, a thorough investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded.No further medical assessment is warranted at this time.Should any additional clinical information be provided this complaint will be re-evaluated.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: UNKN DISPOSABLE BLADE AND BURR
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12476366
• MDR Text Key: 271537627
• Report Number: 1219602-2021-02020
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 11/17/2021
• Supplement Dates FDA Received: 11/18/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other