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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDE BOLT WRENCH ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. GUIDE BOLT WRENCH ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71631140
Device Problems Break (1069); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/13/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that, during trauma surgery, the surgeon was unable to unscrew a trigen 7/16 guide bolt and remove the alignment drill guide. Excessive force was used to loosen the trigen 7/16 guide bolt, which led to breakage of a trigen guide bolt wrench. The tip of the trigen guide bolt wrench got stuck inside the trigen 7/16 guide bolt. The issue was solved by drilling a hole through the trigen 7/16 guide bolt with a metal bur. The alignment guide was removed with a back-up guide bolt wrench. A significant delay was caused as consequence of this problem. No patient injury reported.
 
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Brand NameGUIDE BOLT WRENCH
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key12551066
MDR Text Key273980255
Report Number1020279-2021-07347
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71631140
Device Catalogue Number71631140
Device Lot Number19GM10533
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/29/2021 Patient Sequence Number: 1
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