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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø13X400MM X 125° IMPLANT

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STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø13X400MM X 125° IMPLANT Back to Search Results
Catalog Number 32253400S
Device Problems Break (1069); Crack (1135)
Patient Problem Pain (1994)
Event Date 06/18/2018
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation. Device remains implanted.
 
Event Description
It was reported that the first surgery for pertr. Was performed with a long gamma nail on (b)(6) 2017. Patient came in with pain and non-union. Removal of the nail - mibi samples were collected for the exclusion of infection (there was no infection found). Reosteosynthesis on (b)(6) 2017 with pseudarthrosis removal, allogenic spongiosaplasty, open reduction and cable cerclage and special nail t2: 13 mm diameter, 400 mm in length, 125 ccd. Initial clinical and x-ray controls showed auto dynamization (bolt break distal) and incipient healing, patient fully loaded symptom free, felt cracking on (b)(6)- x-ray-diagnostic - nail breakage. Plan now: revision planned. Date of revision is unknown.
 
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Brand NameLONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø13X400MM X 125°
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7648500
MDR Text Key112702114
Report Number0009610622-2018-00248
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K034002
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 11/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2021
Device Catalogue Number32253400S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/16/2016
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: 06/28/2018 Patient Sequence Number: 1
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