• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X340MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

  • 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
 

STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X340MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3425-0340S
Device Problems Break (1069); Fracture (1260)
Patient Problem Non-union Bone Fracture (2369)
Event Date 01/21/2022
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided on a supplemental report.
 
Event Description
It was reported that the patient fell into the gutter after surgery. It was noted that the nail may have been fractured. Pseudoarthrosis was also identified. The patient underwent the revision surgery on (b)(6) 2022.
 
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided on a supplemental report.
 
Event Description
It was reported that the patient fell into the gutter after surgery. It was noted that the nail may have been fractured. Pseudoarthrosis was also identified. The patient underwent the revision surgery on (b)(6) 2022.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X340MM X 125°
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key13552761
MDR Text Key285955292
Report Number0009610622-2022-00058
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K034002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3425-0340S
Device Catalogue Number34250340S
Device Lot NumberK0B7B56
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/15/2018
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: 02/17/2022 Patient Sequence Number: 1
-
-