Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 10MM; BIT, SURGICAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW, INC. RETROGRADE DRL 10MM; BIT, SURGICAL Back to Search Results
Catalog Number 72204046
Device Problems Break (1069); Difficult to Open or Close (2921)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2024
Event Type  malfunction  
Event Description
It was reported that during a retrograde drilling on the tibia, the spring in the socket that opens the blade gave way on the 10 mm drill, the surgeon was unsure if the blade was open completely.The trunav retrograde drill broke.The procedure was completed with a s+n back up device.It is unknown if there was a surgical delay and no further complications were reported.
 
Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RETROGRADE DRL 10MM
Type of Device
BIT, SURGICAL
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 Key18942979
MDR Text Key338150166
Report Number1219602-2024-00558
Device Sequence Number1
Product Code GFG
UDI-Device Identifier00885554037753
UDI-Public00885554037753
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72204046
Device Lot Number5507118
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/26/2024
Date Device Manufactured04/14/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-