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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. UNKN DISPOSABLE BLADE AND BURR SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Adhesion(s) (1695)
Event Date 05/31/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Article: factor, s. , khoury, a. , atzmon, r. , vidra, m. , amar, e. , & rath, e. (2020). Combined endoscopic and mini-open repair of chronic complete proximal hamstring tendon avulsion: a novel approach and short-term outcomes. Journal of hip preservation surgery, 7(4), 721-727.
 
Event Description
It was reported that on literature review ¿combined endoscopic and mini-open repair of chronic complete proximal hamstring tendon avulsion: a novel approach and short-term outcomes ¿, after surgery with a 3. 5 full radius shaver one patient had subcutaneous scarring requiring revision surgery to lysis of adhesions. No further information is available.
 
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Brand NameUNKN DISPOSABLE BLADE AND BURR
Type of DeviceSAW, 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 Key12472058
MDR Text Key271445890
Report Number1219602-2021-02013
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Study,Literature,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/14/2021 Patient Sequence Number: 1
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