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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPADE DRILL BIT FOR 2.9 ANCHOR SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. SPADE DRILL BIT FOR 2.9 ANCHOR SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72201395
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/28/2021
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: case-(b)(4).
 
Event Description
It was reported that, during ask shoulder, the tip of the spade drill bit for 2. 9 anchor broke off in the glenoid. It broke off in such a way that it sank into the bone and was no longer visible. Procedure was resumed, after a non-significant delay (less or equal to 30min), with a back-up device. No other complications were reported.
 
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Brand NameSPADE DRILL BIT FOR 2.9 ANCHOR
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 Key12647806
MDR Text Key276887198
Report Number1219602-2021-02293
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72201395
Device Catalogue Number72201395
Device Lot Number50226632
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/07/2018
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: 10/18/2021 Patient Sequence Number: 1
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