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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA Ø11X345 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA Ø11X345 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1822-1134S
Device Problem Difficult to Remove (1528)
Patient Problem Discomfort (2330)
Event Date 11/12/2021
Event Type  Injury  
Manufacturer Narrative
The device will not be returned. If additional information becomes available, it will be provided in a supplemental report. Device is not available; device remains implanted in patient.
 
Event Description
As reported: "the nail was implanted on (b)(6) 2015. It is a stryker tibial nail t2 stryker, 345 mm, size 11. Postoperatively, the patient initially underwent partial weight-bearing for 2 weeks and then full weight-bearing depending on the degree of discomfort. The patient was followed up regularly by the surgeon in consultation. The metal removal took place on (b)(6) 2021. All locking pins were removed there - but the nail could not be taken out despite intensive efforts. The nail bothered the patient after 6 1/2 years and he wanted to have it removed. The nail could not be removed during the four-hour surgery, which upset the patient very much. The customer suspects that the nail bent in the lower part and therefore could not be removed. ".
 
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Brand NameTIBIAL NAIL, STANDARD T2 TIBIA Ø11X345 MM
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 Key13737018
MDR Text Key287033905
Report Number0009610622-2022-00089
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K203819
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1822-1134S
Device Catalogue Number18221134S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/21/2022
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: 03/11/2022 Patient Sequence Number: 1
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